510(k) K760170
K760170 is an FDA 510(k) premarket notification submitted by G.D. Searle And Co. for the device "INTRAUTERINE SOUND, PLASTIC DISPOSABLE". The FDA issued a decision of Substantially Equivalent on Jul 19, 1976. The device falls under product code HHM (Sound, Uterine), a Class I device regulated under 21 CFR 884.4530. G.D. Searle And Co. has 55 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 19, 1976
- Date Received
- Jul 6, 1976
- 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
- 510(k) Exempt