The following data is part of a premarket notification filed by Valley Forge Scientific Corp. with the FDA for Valley Forge Bipolar Loop.
| Device ID | K971986 |
| 510k Number | K971986 |
| Device Name: | VALLEY FORGE BIPOLAR LOOP |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | VALLEY FORGE SCIENTIFIC CORP. 136 GREEN TREE RD. P.O. BOX 1179 Oaks, PA 19456 |
| Contact | Jerry L Malis |
| Correspondent | Jerry L Malis VALLEY FORGE SCIENTIFIC CORP. 136 GREEN TREE RD. P.O. BOX 1179 Oaks, PA 19456 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-29 |
| Decision Date | 1997-08-26 |
| Summary: | summary |