The following data is part of a premarket notification filed by Exact Medical Manufacturing, Inc with the FDA for Emm High Performance Surgical Gown With Aami Liquid Barrier Level Iv.
| Device ID | K120045 |
| 510k Number | K120045 |
| Device Name: | EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV |
| 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 | 2012-01-06 |
| Decision Date | 2012-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817602021629 | K120045 | 000 |
| 00850015378270 | K120045 | 000 |
| 00850015378577 | K120045 | 000 |
| 00850015378553 | K120045 | 000 |
| 00850015378539 | K120045 | 000 |
| 00850337007421 | K120045 | 000 |
| 00850024023581 | K120045 | 000 |
| 00850024023567 | K120045 | 000 |
| 00850024023543 | K120045 | 000 |
| 00850031271654 | K120045 | 000 |
| 00850337007292 | K120045 | 000 |
| 10850337007312 | K120045 | 000 |
| 00817602021605 | K120045 | 000 |
| 00817602021582 | K120045 | 000 |
| 00817602021568 | K120045 | 000 |
| 00850003355047 | K120045 | 000 |
| 00850003355023 | K120045 | 000 |
| 10850003355914 | K120045 | 000 |
| 00850337007285 | K120045 | 000 |
| 10850337007077 | K120045 | 000 |
| 00850337007346 | K120045 | 000 |
| 00850031271630 | K120045 | 000 |