510(k) K990738
K990738 is an FDA 510(k) premarket notification submitted by M.S. Jahanger, MD for the device "DR. JAHANGER'S CUTTER". The FDA issued a decision of Substantially Equivalent on October 29, 1999. The device falls under product code KNA (Instrument, Manual, Specialized Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.4530.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 1999
- Date Received
- March 5, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Manual, Specialized Obstetric-Gynecologic
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type