510(k) K813304
K813304 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "CONPHAR, TUNING FORKS". The FDA issued a decision of Substantially Equivalent on December 10, 1981. The device falls under product code GWX (Fork, Tuning), a Class I device regulated under 21 CFR 882.1525. Conphar, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 1981
- Date Received
- November 23, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fork, Tuning
- Device Class
- Class I
- Regulation Number
- 882.1525
- Review Panel
- NE
- Submission Type