The following data is part of a premarket notification filed by Exact Medical Manufacturing, Inc with the FDA for Emm Surgical Drape-spunlace W/pe Sides, Model 13-004.
| Device ID | K101688 |
| 510k Number | K101688 |
| Device Name: | EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 |
| Classification | Drape, 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 | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-16 |
| Decision Date | 2010-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850024023383 | K101688 | 000 |