510(k) K873954
K873954 is an FDA 510(k) premarket notification submitted by North American Instrument Corp. for the device "NAMIC HAWKINS UNIVERSAL DRAINAGE SET". The FDA issued a decision of Substantially Equivalent on January 29, 1988. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. North American Instrument Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 1988
- Date Received
- September 28, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stents, Drains And Dilators For The Biliary Ducts
- Device Class
- Class II
- Regulation Number
- 876.5010
- Review Panel
- GU
- Submission Type