510(k) K781766
K781766 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "UTERINE SOUND, BURNETT DISPOSABLE". The FDA issued a decision of Substantially Equivalent on December 7, 1978. The device falls under product code HHM (Sound, Uterine), a Class I device regulated under 21 CFR 884.4530. 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
- Sound, Uterine
- Device Class
- Class I
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type