510(k) K791350
K791350 is an FDA 510(k) premarket notification submitted by Hospital Products Co. for the device "POPE AMBULATORY HALO VEST". The FDA issued a decision of Substantially Equivalent on August 3, 1979. The device falls under product code IQF (Orthosis, Cervical-Thoracic, Rigid), a Class I device regulated under 21 CFR 890.3490. Hospital Products Co. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 3, 1979
- Date Received
- July 17, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Cervical-Thoracic, Rigid
- Device Class
- Class I
- Regulation Number
- 890.3490
- Review Panel
- PM
- Submission Type