The following data is part of a premarket notification filed by J.j. Skinner, Inc. with the FDA for Carekits(tm) Incision/drainage/suture Removal Kits.
| Device ID | K903544 |
| 510k Number | K903544 |
| Device Name: | CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS |
| Classification | Tray, Surgical |
| Applicant | J.J. SKINNER, INC. C/O MEDICAL DEVICE INSPECTION 55 NORTHERN BLVD., SUITE 301 Great Neck, NY 11021 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz J.J. SKINNER, INC. C/O MEDICAL DEVICE INSPECTION 55 NORTHERN BLVD., SUITE 301 Great Neck, NY 11021 |
| Product Code | LRP |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-06 |
| Decision Date | 1990-08-31 |