510(k) K792106
K792106 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "CONPHAR O.R. HEAD COVER-STERILE". The FDA issued a decision of Substantially Equivalent on November 5, 1979. The device falls under product code FYI (Appliance, Facial Fracture, External), a Class I device regulated under 21 CFR 878.3250. Conphar, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 1979
- Date Received
- October 25, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Facial Fracture, External
- Device Class
- Class I
- Regulation Number
- 878.3250
- Review Panel
- SU
- Submission Type