The following data is part of a premarket notification filed by Microtek Medical, Inc. with the FDA for Freedomaire Iii Surgical Helmet System Model 10322stk.
| Device ID | K102971 |
| 510k Number | K102971 |
| Device Name: | FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK |
| Classification | Gown, Surgical |
| Applicant | MICROTEK MEDICAL, INC. 602 LEHMBERG RD. Columbus, MS 39702 |
| Contact | Thomas B Bonner, Jr. |
| Correspondent | Thomas B Bonner, Jr. MICROTEK MEDICAL, INC. 602 LEHMBERG RD. Columbus, MS 39702 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-06 |
| Decision Date | 2011-02-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50748426090889 | K102971 | 000 |