510(k) K780422
K780422 is an FDA 510(k) premarket notification submitted by Projects IN Health for the device "PINWHEEL". The FDA issued a decision of Substantially Equivalent on April 4, 1978. The device falls under product code GWY (Pinwheel), a Class I device regulated under 21 CFR 882.1750. Projects IN Health has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 1978
- Date Received
- March 17, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pinwheel
- Device Class
- Class I
- Regulation Number
- 882.1750
- Review Panel
- NE
- Submission Type