The following data is part of a premarket notification filed by Jayco Pharmaceuticals with the FDA for Endoscopic Multiple Biopsy Instrument.
| Device ID | K844690 |
| 510k Number | K844690 |
| Device Name: | ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT |
| Classification | Forceps, Biopsy, Non-electric |
| Applicant | JAYCO PHARMACEUTICALS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Contact | Lester J Lifton |
| Correspondent | Lester J Lifton JAYCO PHARMACEUTICALS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Product Code | FCL |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-03 |
| Decision Date | 1985-01-02 |