The following data is part of a premarket notification filed by Kolster Methods with the FDA for Canula Suction For Surgical General And Plastic.
Device ID | K895762 |
510k Number | K895762 |
Device Name: | CANULA SUCTION FOR SURGICAL GENERAL AND PLASTIC |
Classification | Cannula, Surgical, General & Plastic Surgery |
Applicant | KOLSTER METHODS 1895 W. COMMONWEALTH AVE. UNIT 'G' Fullerton, CA 92633 |
Contact | Alwin Kolster |
Correspondent | Alwin Kolster KOLSTER METHODS 1895 W. COMMONWEALTH AVE. UNIT 'G' Fullerton, CA 92633 |
Product Code | GEA |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-09-26 |
Decision Date | 1989-10-18 |