510(k) K002971
K002971 is an FDA 510(k) premarket notification submitted by Zander Medical Supplies, Inc. for the device "MTG - MINITUB HEATED STAGE SYSTEMS". The FDA issued a decision of Substantially Equivalent on December 15, 2000. The device falls under product code MQG (Accessory, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6120. Zander Medical Supplies, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 2000
- Date Received
- September 22, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessory, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6120
- Review Panel
- OB
- Submission Type