The following data is part of a premarket notification filed by North American Sterilization & Packaging Co. with the FDA for Nasp Hydrocolloid Dressing (regular Or Thin).
| Device ID | K964231 |
| 510k Number | K964231 |
| Device Name: | NASP HYDROCOLLOID DRESSING (REGULAR OR THIN) |
| Classification | Bandage, Liquid |
| Applicant | NORTH AMERICAN STERILIZATION & PACKAGING CO. 18 WHITE LAKE RD. Sparta, NJ 07871 |
| Contact | Charles E Meisch |
| Correspondent | Charles E Meisch NORTH AMERICAN STERILIZATION & PACKAGING CO. 18 WHITE LAKE RD. Sparta, NJ 07871 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-23 |
| Decision Date | 1997-03-10 |