The following data is part of a premarket notification filed by Medgyn Products, Inc. with the FDA for Bottle Collection Set.
| Device ID | K945179 |
| 510k Number | K945179 |
| Device Name: | BOTTLE COLLECTION SET |
| Classification | Source, Abortion Unit, Vacuum |
| Applicant | MEDGYN PRODUCTS, INC. 328 NORTH EISENHOWER LN. Lombard, IL 60148 |
| Contact | Lakshman Agadi |
| Correspondent | Lakshman Agadi MEDGYN PRODUCTS, INC. 328 NORTH EISENHOWER LN. Lombard, IL 60148 |
| Product Code | HGF |
| CFR Regulation Number | 884.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-24 |
| Decision Date | 1995-01-26 |