The following data is part of a premarket notification filed by Hangzhou Atek Medical & Textile Co., Ltd with the FDA for Atek Surgical Gowns.
| Device ID | K100971 |
| 510k Number | K100971 |
| Device Name: | ATEK SURGICAL GOWNS |
| Classification | Gown, Surgical |
| Applicant | HANGZHOU ATEK MEDICAL & TEXTILE CO., LTD 1340 WEST PENNSYLVANIA AVENUE San Diego, CA 92103 |
| Contact | Glen Feye |
| Correspondent | Glen Feye HANGZHOU ATEK MEDICAL & TEXTILE CO., LTD 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 | 2010-04-08 |
| Decision Date | 2010-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06950471300083 | K100971 | 000 |