Shave Prep Kit
General, Plastic Surgery · 21 CFR 878.4370
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
11 firms currently registered for this product code
Vectracor, Inc.
Totowa, NJ, US
Midwest Sterilization Corp.
JACKSON, MO, US
Isomedix Operations Inc
El Paso, TX, US
Midwest Sterilization Corp.
LAREDO, TX, US
Shenzhen Fox Hunting E-commerce Co., Ltd
Shenzhen Guangdong, CN
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Isomedix Operations Inc
EL PASO, TX, US
Cardinal Health 200, Llc
Waukegan, IL, US
Sterigenics Us Llc
Grand Prairie, TX, US
Cardinal Health 200, Llc
El Paso, TX, US
Sterigenics U.s., Llc
Charlotte, NC, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.