The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Sheer Adhesive Bandages, Sterile.
| Device ID | K850529 |
| 510k Number | K850529 |
| Device Name: | SHEER ADHESIVE BANDAGES, STERILE |
| Classification | Tape And Bandage, Adhesive |
| 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 | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-11 |
| Decision Date | 1985-05-10 |