The following data is part of a premarket notification filed by Sultan Chemists, Inc. with the FDA for Assure, Self-sealing Sterilization Pouch.
| Device ID | K951590 |
| 510k Number | K951590 |
| Device Name: | ASSURE, SELF-SEALING STERILIZATION POUCH |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | SULTAN CHEMISTS, INC. 85 W. FOREST AVE. Englewood, NJ 07631 |
| Contact | Paul Seid |
| Correspondent | Paul Seid SULTAN CHEMISTS, INC. 85 W. FOREST AVE. Englewood, NJ 07631 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-06 |
| Decision Date | 1995-05-17 |