The following data is part of a premarket notification filed by Palex Medical, Inc. with the FDA for Lamin-add Adhesive Surgical Drape & Cath. Dressing.
| Device ID | K900945 |
| 510k Number | K900945 |
| Device Name: | LAMIN-ADD ADHESIVE SURGICAL DRAPE & CATH. DRESSING |
| Classification | Drape, Surgical |
| Applicant | PALEX MEDICAL, INC. ONE LETHBRIDGE PLAZA SUITE 7 Mahwah, NJ 07430 |
| Contact | Kelly, Md |
| Correspondent | Kelly, Md PALEX MEDICAL, INC. ONE LETHBRIDGE PLAZA SUITE 7 Mahwah, NJ 07430 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-28 |
| Decision Date | 1990-05-09 |