510(k) K803147
K803147 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "CONPHAR ADJUSTABLE CERVICAL COLLAR". The FDA issued a decision of Substantially Equivalent on Jan 8, 1981. The device falls under product code IQK (Orthosis, Cervical), a Class I device regulated under 21 CFR 890.3490. Conphar, Inc. has 121 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 8, 1981
- Date Received
- Dec 12, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Orthosis, Cervical
- Device Class
- Class I
- Regulation Number
- 890.3490
- Review Panel
- PM
- Submission Type
- 510(k) Exempt