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 |