The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Abco Drapes/towels.
Device ID | K851314 |
510k Number | K851314 |
Device Name: | ABCO DRAPES/TOWELS |
Classification | Drape, Surgical |
Applicant | ABCO DEALERS, INC. P.O. BOX 17587 6637 NORTH SIDNEY PLACE Milwaukee, WI 53217 |
Contact | Christine Nemeth |
Correspondent | Christine Nemeth ABCO DEALERS, INC. P.O. BOX 17587 6637 NORTH SIDNEY PLACE Milwaukee, WI 53217 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-02 |
Decision Date | 1985-05-01 |