510(k) K874022
K874022 is an FDA 510(k) premarket notification submitted by American Pharmaseal Div. Ahsc for the device "PHARMASEAL WOUND IRRIGATION DEVICE". The FDA issued a decision of Substantially Equivalent on December 30, 1987. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475. American Pharmaseal Div. Ahsc has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 1987
- Date Received
- October 2, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lavage, Jet
- Device Class
- Class II
- Regulation Number
- 880.5475
- Review Panel
- HO
- Submission Type