The following data is part of a premarket notification filed by Carl Parker Associates, Inc. with the FDA for Defend Self-sealing Sterilization Pouch.
| Device ID | K932056 |
| 510k Number | K932056 |
| Device Name: | DEFEND SELF-SEALING STERILIZATION POUCH |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | CARL PARKER ASSOCIATES, INC. 175M COMMERCE DR. P.O. BOX 12084 Hauppauge, NY 11788 |
| Contact | Andrew M Parker |
| Correspondent | Andrew M Parker CARL PARKER ASSOCIATES, INC. 175M COMMERCE DR. P.O. BOX 12084 Hauppauge, NY 11788 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-28 |
| Decision Date | 1994-07-13 |