The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Non-skid Shoe Covers.
Device ID | K872797 |
510k Number | K872797 |
Device Name: | NON-SKID SHOE COVERS |
Classification | Cover, Shoe, Operating-room |
Applicant | ABCO DEALERS, INC. 6601 W. MILL RD. P.O. BOX 23090 Milwaukee, WI 53218 -1238 |
Contact | Molly Pribek |
Correspondent | Molly Pribek ABCO DEALERS, INC. 6601 W. MILL RD. P.O. BOX 23090 Milwaukee, WI 53218 -1238 |
Product Code | FXP |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-15 |
Decision Date | 1987-08-04 |