The following data is part of a premarket notification filed by J.j. Skinner, Inc. with the FDA for Carekits(tm), Iv/cath/cent Line Dress/tpn/cvp Kits.
| Device ID | K903545 |
| 510k Number | K903545 |
| Device Name: | CAREKITS(TM), IV/CATH/CENT LINE DRESS/TPN/CVP KITS |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| 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 | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-06 |
| Decision Date | 1990-11-13 |