The following data is part of a premarket notification filed by Zander Medical Supplies, Inc. with the FDA for Db1 Embryo Freeze.
| Device ID | K011327 |
| 510k Number | K011327 |
| Device Name: | DB1 EMBRYO FREEZE |
| Classification | Accessory, Assisted Reproduction |
| Applicant | ZANDER MEDICAL SUPPLIES, INC. 755 8TH CT., SUITE #4 P.O.650790 Vero Beach, FL 32962 |
| Contact | Fred Zander |
| Correspondent | Fred Zander ZANDER MEDICAL SUPPLIES, INC. 755 8TH CT., SUITE #4 P.O.650790 Vero Beach, FL 32962 |
| Product Code | MQG |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-01 |
| Decision Date | 2002-08-15 |