The following data is part of a premarket notification filed by Welmed Inc. with the FDA for Welmed, Inc. Surgical Gowns.
| Device ID | K070431 |
| 510k Number | K070431 |
| Device Name: | WELMED, INC. SURGICAL GOWNS |
| Classification | Gown, Surgical |
| Applicant | WELMED INC. 1340 WEST PENNSYLVANIA AVENUE San Diego, CA 92103 |
| Contact | Glen Feye |
| Correspondent | Glen Feye WELMED INC. 1340 WEST PENNSYLVANIA AVENUE San Diego, CA 92103 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-13 |
| Decision Date | 2007-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50749756884889 | K070431 | 000 |
| 50749756354788 | K070431 | 000 |
| 50749756354795 | K070431 | 000 |
| 00849296000574 | K070431 | 000 |
| 00849296005258 | K070431 | 000 |
| 10849296007396 | K070431 | 000 |
| 50749756566105 | K070431 | 000 |
| 50749756566129 | K070431 | 000 |
| 50749756566136 | K070431 | 000 |
| 50749756566150 | K070431 | 000 |
| 50749756566228 | K070431 | 000 |
| 50749756566235 | K070431 | 000 |
| 50749756566297 | K070431 | 000 |
| 50749756566327 | K070431 | 000 |
| 50749756566334 | K070431 | 000 |
| 50749756566365 | K070431 | 000 |
| 50749756354771 | K070431 | 000 |