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 |