The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Dobbhoff(r) Bipolar Hemostatic Probe.
| Device ID | K912129 |
| 510k Number | K912129 |
| Device Name: | DOBBHOFF(R) BIPOLAR HEMOSTATIC PROBE |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville, NJ 08876 |
| Contact | Matthew W Lesnieski |
| Correspondent | Matthew W Lesnieski BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville, NJ 08876 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-14 |
| Decision Date | 1991-08-07 |