The following data is part of a premarket notification filed by E.m. Adams with the FDA for Sterile Disposable Drape(s).
| Device ID | K910468 |
| 510k Number | K910468 |
| Device Name: | STERILE DISPOSABLE DRAPE(S) |
| Classification | Apparatus, Air Handling, Enclosure |
| Applicant | E.M. ADAMS 121 WEST ST. Medfield, MA 02052 |
| Contact | Richard K Donahue |
| Correspondent | Richard K Donahue E.M. ADAMS 121 WEST ST. Medfield, MA 02052 |
| Product Code | FZI |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-04 |
| Decision Date | 1991-03-21 |