The following data is part of a premarket notification filed by Zander Medical Supplies, Inc. with the FDA for Mtg - Minitub Heated Stage Systems.
| Device ID | K002971 |
| 510k Number | K002971 |
| Device Name: | MTG - MINITUB HEATED STAGE SYSTEMS |
| Classification | Accessory, Assisted Reproduction |
| Applicant | ZANDER MEDICAL SUPPLIES, INC. 755 8TH CT., SUITE #4 P.O.650790 Vero Beach, FL 32965 -0790 |
| Contact | Friedel Mw Zander |
| Correspondent | Friedel Mw Zander ZANDER MEDICAL SUPPLIES, INC. 755 8TH CT., SUITE #4 P.O.650790 Vero Beach, FL 32965 -0790 |
| Product Code | MQG |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-22 |
| Decision Date | 2000-12-15 |