510(k) K993699
K993699 is an FDA 510(k) premarket notification submitted by Mid-Atlantic Diagnostics, Inc. for the device "THE STRIPPER". The FDA issued a decision of Substantially Equivalent on May 16, 2000. The device falls under product code MQH (Microtools, Assisted Reproduction (Pipettes)), a Class II device regulated under 21 CFR 884.6130. Mid-Atlantic Diagnostics, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 2000
- Date Received
- November 2, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Microtools, Assisted Reproduction (Pipettes)
- Device Class
- Class II
- Regulation Number
- 884.6130
- Review Panel
- OB
- Submission Type