The following data is part of a premarket notification filed by Peregrine Surgical Ltd. with the FDA for Peregrine Fiber Optic Multi-function Manipulator.
| Device ID | K980797 |
| 510k Number | K980797 |
| Device Name: | PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR |
| Classification | Endoilluminator |
| Applicant | PEREGRINE SURGICAL LTD. 4050 D SKYRON DR. Doylestown, PA 18901 |
| Contact | Todd Richmond |
| Correspondent | Todd Richmond PEREGRINE SURGICAL LTD. 4050 D SKYRON DR. Doylestown, PA 18901 |
| Product Code | MPA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-02 |
| Decision Date | 1998-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10632307002189 | K980797 | 000 |
| 10632307001120 | K980797 | 000 |
| 10632307001113 | K980797 | 000 |
| 10632307001106 | K980797 | 000 |
| 10632307001045 | K980797 | 000 |
| 10632307000864 | K980797 | 000 |
| 10632307000994 | K980797 | 000 |
| 10632307000987 | K980797 | 000 |
| 10632307000970 | K980797 | 000 |
| 10632307000963 | K980797 | 000 |
| 10632307000956 | K980797 | 000 |
| 10632307000871 | K980797 | 000 |
| 10632307000338 | K980797 | 000 |
| 10632307000246 | K980797 | 000 |
| 10632307001168 | K980797 | 000 |
| 10632307001175 | K980797 | 000 |
| 10632307001458 | K980797 | 000 |
| 10632307001441 | K980797 | 000 |
| 10632307001434 | K980797 | 000 |
| 10632307001427 | K980797 | 000 |
| 10632307001342 | K980797 | 000 |
| 10632307001335 | K980797 | 000 |
| 10632307001328 | K980797 | 000 |
| 10632307001311 | K980797 | 000 |
| 10632307001281 | K980797 | 000 |
| 10632307001267 | K980797 | 000 |
| 10632307001243 | K980797 | 000 |
| 10632307001229 | K980797 | 000 |
| 10632307001212 | K980797 | 000 |
| 10632307000192 | K980797 | 000 |