510(k) K030948
K030948 is an FDA 510(k) premarket notification submitted by Howard Instruments, Inc. for the device "VMATE MODEL VMM1000". The FDA issued a decision of Substantially Equivalent on June 17, 2003. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Howard Instruments, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 2003
- Date Received
- March 26, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.4150
- Review Panel
- OP
- Submission Type