The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for Posi-grip Umbilical Cord Clamp, Sterile, Model 384, Posi-grip Umbilical Cord Clamp, Non-sterile, Model 385.
| Device ID | K010835 |
| 510k Number | K010835 |
| Device Name: | POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385 |
| Classification | Clamp, Umbilical |
| Applicant | BUSSE HOSPITAL DISPOSABLES, INC. 75 ARKAY DR. Hauppauge, NY 11788 |
| Contact | Vicki Ator |
| Correspondent | Vicki Ator BUSSE HOSPITAL DISPOSABLES, INC. 75 ARKAY DR. Hauppauge, NY 11788 |
| Product Code | HFW |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-20 |
| Decision Date | 2001-04-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10849233018102 | K010835 | 000 |
| 20849233013036 | K010835 | 000 |