510(k) K790954
K790954 is an FDA 510(k) premarket notification submitted by Fem-Gard, Inc. for the device "HEEL GARD". The FDA issued a decision of Substantially Equivalent on June 20, 1979. The device falls under product code FRK (Chair, Examination And Treatment), a Class I device regulated under 21 CFR 880.6140. Fem-Gard, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 1979
- Date Received
- May 22, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chair, Examination And Treatment
- Device Class
- Class I
- Regulation Number
- 880.6140
- Review Panel
- HO
- Submission Type