The following data is part of a premarket notification filed by Adroit Medical Systems, Inc. with the FDA for Safepass Sterilization Pouch.
| Device ID | K973981 |
| 510k Number | K973981 |
| Device Name: | SAFEPASS STERILIZATION POUCH |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | ADROIT MEDICAL SYSTEMS, INC. 1146 CARDING MACHINE RD. Loudon, TN 37774 |
| Contact | Richard L Studer |
| Correspondent | Richard L Studer ADROIT MEDICAL SYSTEMS, INC. 1146 CARDING MACHINE RD. Loudon, TN 37774 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-20 |
| Decision Date | 1998-01-29 |
| Summary: | summary |