The following data is part of a premarket notification filed by J.j. Skinner, Inc. with the FDA for Jj Skinner Carekits(tm) Dry/wet/gel Skin Scrub Kit.
Device ID | K925467 |
510k Number | K925467 |
Device Name: | JJ SKINNER CAREKITS(TM) DRY/WET/GEL SKIN SCRUB KIT |
Classification | General Surgery Tray |
Applicant | J.J. SKINNER, INC. C/O MEDICAL DEVICE INSPECTION 55 NORTHERN BLVD., SUITE 301 Great Neck, NY 11021 |
Contact | Alan I Becker |
Correspondent | Alan I Becker J.J. SKINNER, INC. C/O MEDICAL DEVICE INSPECTION 55 NORTHERN BLVD., SUITE 301 Great Neck, NY 11021 |
Product Code | LRO |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-29 |
Decision Date | 1994-05-11 |