The following data is part of a premarket notification filed by Exact Medical Manufacturing, Inc with the FDA for Emm Surgical Gown - Spunlace With Pe Layer.
| Device ID | K111535 |
| 510k Number | K111535 |
| Device Name: | EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER |
| Classification | Gown, Surgical |
| Applicant | EXACT MEDICAL MANUFACTURING, INC 1083 DELAWARE AVE Buffalo, NY 14209 |
| Contact | Robert O Dean |
| Correspondent | Robert O Dean EXACT MEDICAL MANUFACTURING, INC 1083 DELAWARE AVE Buffalo, NY 14209 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-02 |
| Decision Date | 2011-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26975085709125 | K111535 | 000 |
| 26975085708517 | K111535 | 000 |