The following data is part of a premarket notification filed by Stackhouse Assoc. with the FDA for Freedom Mark Iii Surgical Helmet System.
| Device ID | K910515 |
| 510k Number | K910515 |
| Device Name: | FREEDOM MARK III SURGICAL HELMET SYSTEM |
| Classification | Gown, Surgical |
| Applicant | STACKHOUSE ASSOC. 2059 ATLANTA AVE. Riverside, CA 92507 |
| Contact | Green, Jr. |
| Correspondent | Green, Jr. STACKHOUSE ASSOC. 2059 ATLANTA AVE. Riverside, CA 92507 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-05 |
| Decision Date | 1991-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50748426102803 | K910515 | 000 |
| 50748426095754 | K910515 | 000 |
| 50748426089791 | K910515 | 000 |
| 50748426090117 | K910515 | 000 |
| 50748426090896 | K910515 | 000 |
| 50748426090919 | K910515 | 000 |
| 50748426091602 | K910515 | 000 |
| 50748426095488 | K910515 | 000 |
| 50748426095518 | K910515 | 000 |
| 50748426095532 | K910515 | 000 |
| 50748426095846 | K910515 | 000 |
| 50748426095501 | K910515 | 000 |