510(k) K822735
K822735 is an FDA 510(k) premarket notification submitted by Geneva Laboratories, Inc. for the device "SURE-COUNT DISPOSABLE NEEDLE COUNTER". The FDA issued a decision of Substantially Equivalent on March 9, 1983. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Geneva Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 1983
- Date Received
- September 9, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, Sharps
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type