The following data is part of a premarket notification filed by Britt Corp., Inc. with the FDA for Model 525 - 25 Watt Co2 Medical Laser/podiatry.
Device ID | K860273 |
510k Number | K860273 |
Device Name: | MODEL 525 - 25 WATT CO2 MEDICAL LASER/PODIATRY |
Classification | Powered Laser Surgical Instrument |
Applicant | BRITT CORP., INC. C/O WECK SURGICAL SYSTEMS INC. 686 OLD WILLETS PATH Hauppague, NY 11788 |
Contact | Jeffrey Green |
Correspondent | Jeffrey Green BRITT CORP., INC. C/O WECK SURGICAL SYSTEMS INC. 686 OLD WILLETS PATH Hauppague, NY 11788 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-27 |
Decision Date | 1986-04-23 |