The following data is part of a premarket notification filed by Kolster Methods with the FDA for Kolster Methods.
Device ID | K935820 |
510k Number | K935820 |
Device Name: | KOLSTER METHODS |
Classification | Cannula, Suction, Uterine |
Applicant | KOLSTER METHODS 2550 W. ROWLAND AVE. Anaheim, CA 92804 |
Contact | Alvin Kolster |
Correspondent | Alvin Kolster KOLSTER METHODS 2550 W. ROWLAND AVE. Anaheim, CA 92804 |
Product Code | HGH |
CFR Regulation Number | 884.5070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-03 |
Decision Date | 1994-07-19 |