The following data is part of a premarket notification filed by Sterimed, Inc. with the FDA for Drape Stericover.
| Device ID | K863512 |
| 510k Number | K863512 |
| Device Name: | DRAPE STERICOVER |
| Classification | Drape, Surgical |
| Applicant | STERIMED, INC. P.O. BOX #686 Acworth, GA 30101 |
| Contact | Bruce R Grady |
| Correspondent | Bruce R Grady STERIMED, INC. P.O. BOX #686 Acworth, GA 30101 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-09 |
| Decision Date | 1986-09-30 |