The following data is part of a premarket notification filed by Omnia Spa with the FDA for Surgical Procedure Packs.
| Device ID | K110724 |
| 510k Number | K110724 |
| Device Name: | SURGICAL PROCEDURE PACKS |
| Classification | Gown, Surgical |
| Applicant | OMNIA SPA 11460 N MERIDIAN STREET SUITE 150 Carmel, IN 46032 |
| Contact | Jamie Austin |
| Correspondent | Jamie Austin OMNIA SPA 11460 N MERIDIAN STREET SUITE 150 Carmel, IN 46032 |
| Product Code | FYA |
| Subsequent Product Code | FXX |
| Subsequent Product Code | KKX |
| Subsequent Product Code | LRO |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-16 |
| Decision Date | 2011-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 8056646500239 | K110724 | 000 |
| 08056646500840 | K110724 | 000 |
| 18056646502469 | K110724 | 000 |
| 18056646502452 | K110724 | 000 |
| 18056646502445 | K110724 | 000 |
| 08056646502431 | K110724 | 000 |