The following data is part of a premarket notification filed by (arms) Hoffman Surgical Equipment, Ivf Division with the FDA for Hoffman Ivf-1.
| Device ID | K991216 |
| 510k Number | K991216 |
| Device Name: | HOFFMAN IVF-1 |
| Classification | Accessory, Assisted Reproduction |
| Applicant | (ARMS) HOFFMAN SURGICAL EQUIPMENT, IVF DIVISION 555 NORTH LN. SUITE 5001 Conshohocken, PA 19428 |
| Contact | Frank Strzempek |
| Correspondent | Frank Strzempek (ARMS) HOFFMAN SURGICAL EQUIPMENT, IVF DIVISION 555 NORTH LN. SUITE 5001 Conshohocken, PA 19428 |
| Product Code | MQG |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-09 |
| Decision Date | 1999-08-05 |