The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for Skin Staple Remover With Sponge Sterile Disposable.
| Device ID | K861711 |
| 510k Number | K861711 |
| Device Name: | SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE |
| Classification | Staple, Removable (skin) |
| Applicant | BUSSE HOSPITAL DISPOSABLES, INC. P.O. BOX 11067 Hauppauge, NY 11788 |
| Contact | Partha Basumallik |
| Correspondent | Partha Basumallik BUSSE HOSPITAL DISPOSABLES, INC. P.O. BOX 11067 Hauppauge, NY 11788 |
| Product Code | GDT |
| CFR Regulation Number | 878.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-05 |
| Decision Date | 1986-05-16 |