The following data is part of a premarket notification filed by Exact Medical Manufacturing, Inc with the FDA for Surgical Drape With Aami Liquid Barrier Level Iv.
| Device ID | K121919 |
| 510k Number | K121919 |
| Device Name: | SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV |
| 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 | 2012-07-02 |
| Decision Date | 2013-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866001000360 | K121919 | 000 |