510(k) K822194
K822194 is an FDA 510(k) premarket notification submitted by Kelleher Corp. for the device "ENDOSCOPIC SPONGE CARRIER". The FDA issued a decision of Substantially Equivalent on August 27, 1982. The device falls under product code FGS (Carrier, Sponge, Endoscopic), a Class II device regulated under 21 CFR 876.1500. Kelleher Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 1982
- Date Received
- July 23, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Carrier, Sponge, Endoscopic
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type