The following data is part of a premarket notification filed by Pfizer Laser Systems with the FDA for Pegasus With Accessories.
Device ID | K903027 |
510k Number | K903027 |
Device Name: | PEGASUS WITH ACCESSORIES |
Classification | Powered Laser Surgical Instrument |
Applicant | PFIZER LASER SYSTEMS 3 MORGAN Irvine, CA 92718 |
Contact | Colette Cozean |
Correspondent | Colette Cozean PFIZER LASER SYSTEMS 3 MORGAN Irvine, CA 92718 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-10 |
Decision Date | 1990-10-02 |