The following data is part of a premarket notification filed by Dept. Of The Army with the FDA for Sterilizer, Surg Instr/dressing #6530-01-306-9510.
| Device ID | K921613 |
| 510k Number | K921613 |
| Device Name: | STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510 |
| Classification | Sterilizer, Steam |
| Applicant | DEPT. OF THE ARMY 5109 LEESBURG PIKE Falls Church, VA 22041 |
| Contact | Gregory P Berezuk |
| Correspondent | Gregory P Berezuk DEPT. OF THE ARMY 5109 LEESBURG PIKE Falls Church, VA 22041 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-06 |
| Decision Date | 1993-01-29 |