The following data is part of a premarket notification filed by Thai Hospital Products Co., Ltd. with the FDA for Mask, Surgical Apparel.
| Device ID | K911334 |
| 510k Number | K911334 |
| Device Name: | MASK, SURGICAL APPAREL |
| Classification | Mask, Surgical |
| Applicant | THAI HOSPITAL PRODUCTS CO., LTD. 173 MOO 5 THATOOM, SRIMAHAPOTHI Prachinburi, TH 25140 |
| Contact | Thawatchai Maturapor |
| Correspondent | Thawatchai Maturapor THAI HOSPITAL PRODUCTS CO., LTD. 173 MOO 5 THATOOM, SRIMAHAPOTHI Prachinburi, TH 25140 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-26 |
| Decision Date | 1991-08-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00609626062661 | K911334 | 000 |
| 08056646501328 | K911334 | 000 |
| 08056646501342 | K911334 | 000 |
| 08056646501366 | K911334 | 000 |
| 08056646501380 | K911334 | 000 |
| 08056646501403 | K911334 | 000 |
| 08056646501427 | K911334 | 000 |
| 08056646501441 | K911334 | 000 |
| 08056646503216 | K911334 | 000 |
| 00609626000007 | K911334 | 000 |
| 00609626000021 | K911334 | 000 |
| 00609626000038 | K911334 | 000 |
| 00609626062630 | K911334 | 000 |
| 00609626062647 | K911334 | 000 |
| 08056646501298 | K911334 | 000 |