The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Disposable Shoe Covers And Nurses Caps.
| Device ID | K862726 |
| 510k Number | K862726 |
| Device Name: | DISPOSABLE SHOE COVERS AND NURSES CAPS |
| Classification | Cover, Shoe, Operating-room |
| Applicant | ABCO DEALERS, INC. P.O. BOX 17587 6637 NORTH SIDNEY PLACE Milwaukee, WI 53217 |
| Contact | Piyush M Shah |
| Correspondent | Piyush M Shah ABCO DEALERS, INC. P.O. BOX 17587 6637 NORTH SIDNEY PLACE Milwaukee, WI 53217 |
| Product Code | FXP |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-18 |
| Decision Date | 1986-08-01 |