510(k) K822421
K822421 is an FDA 510(k) premarket notification submitted by Innovative Products, Inc. for the device "INNOCOMB LICE COMB". The FDA issued a decision of Substantially Equivalent on October 13, 1982. The device falls under product code LJL (Detectors And Removers, Lice, (Including Combs)), a Class I device regulated under 21 CFR 880.5960. Innovative Products, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 1982
- Date Received
- August 16, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Detectors And Removers, Lice, (Including Combs)
- Device Class
- Class I
- Regulation Number
- 880.5960
- Review Panel
- HO
- Submission Type