The following data is part of a premarket notification filed by Peregrine Surgical Ltd. with the FDA for Peregrine Pic Minipulator.
Device ID | K940392 |
510k Number | K940392 |
Device Name: | PEREGRINE PIC MINIPULATOR |
Classification | Device, Irrigation, Ocular Surgery |
Applicant | PEREGRINE SURGICAL LTD. 73 OLD DUBLIN PIKE Doylestown, PA 18901 |
Contact | John E Richmond |
Correspondent | John E Richmond PEREGRINE SURGICAL LTD. 73 OLD DUBLIN PIKE Doylestown, PA 18901 |
Product Code | KYG |
CFR Regulation Number | 886.4360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-26 |
Decision Date | 1994-08-23 |