510(k) K781767
K781767 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "INSTRUMENT CURNETT MINI-CONER BIOPSY". The FDA issued a decision of Substantially Equivalent on December 7, 1978. The device falls under product code KOH (Instrument, Manual, General Obstetric-Gynecologic), a Class I device regulated under 21 CFR 884.4520. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 1978
- Date Received
- October 16, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Manual, General Obstetric-Gynecologic
- Device Class
- Class I
- Regulation Number
- 884.4520
- Review Panel
- OB
- Submission Type