The following data is part of a premarket notification filed by Austin Medical, Inc. with the FDA for Surgical Drapes.
| Device ID | K061422 |
| 510k Number | K061422 |
| Device Name: | SURGICAL DRAPES |
| Classification | Drape, Surgical |
| Applicant | AUSTIN MEDICAL, INC. 3460 POINTE CREEK CT. #102 Bonita Springs, FL 34134 -2015 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden AUSTIN MEDICAL, INC. 3460 POINTE CREEK CT. #102 Bonita Springs, FL 34134 -2015 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-23 |
| Decision Date | 2006-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866001000346 | K061422 | 000 |
| 10866001000329 | K061422 | 000 |
| 00866001000315 | K061422 | 000 |