The following data is part of a premarket notification filed by Dermacare Products, Inc. with the FDA for Elan-e Disposalbe Drape.
Device ID | K882494 |
510k Number | K882494 |
Device Name: | ELAN-E DISPOSALBE DRAPE |
Classification | Drape, Surgical |
Applicant | DERMACARE PRODUCTS, INC. 7651 NATIONAL TURNPIKE Louisville, KT 40214 |
Contact | Ken J Potts |
Correspondent | Ken J Potts DERMACARE PRODUCTS, INC. 7651 NATIONAL TURNPIKE Louisville, KT 40214 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-16 |
Decision Date | 1988-07-08 |