The following data is part of a premarket notification filed by Exact Medical Manufacturing, Inc with the FDA for Emm Surgical Gown-sms With Pe Layer, Model 18-501 L, 18-501-xl, 18-501 Xxl, 18-501-xlxl.
| Device ID | K101593 |
| 510k Number | K101593 |
| Device Name: | EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL |
| 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 | 2010-06-08 |
| Decision Date | 2010-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10352410702843 | K101593 | 000 |