510(k) K952585
K952585 is an FDA 510(k) premarket notification submitted by Gamp & Assoc. for the device "GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR". The FDA issued a decision of Substantially Equivalent on January 5, 1996. The device falls under product code MPA (Endoilluminator), a Class II device regulated under 21 CFR 876.1500. Gamp & Assoc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 5, 1996
- Date Received
- June 5, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoilluminator
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- OP
- Submission Type