510(k) K950267
K950267 is an FDA 510(k) premarket notification submitted by Applied Medical Resources for the device "URETHRAL SUTURE GUIDE". The FDA issued a decision of Substantially Equivalent on January 31, 1995. The device falls under product code KOA (Surgical Instruments, G-U, Manual (And Accessories)), a Class I device regulated under 21 CFR 876.4730. Applied Medical Resources has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 1995
- Date Received
- January 23, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Surgical Instruments, G-U, Manual (And Accessories)
- Device Class
- Class I
- Regulation Number
- 876.4730
- Review Panel
- GU
- Submission Type