510(k) K943598
K943598 is an FDA 510(k) premarket notification submitted by Optimed Technologies, Inc. for the device "FLEXIBLE FIBER OPTIC LAPAROSCOPES". The FDA issued a decision of Substantially Equivalent on October 18, 1994. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Optimed Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 1994
- Date Received
- July 26, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laparoscope, Gynecologic (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1720
- Review Panel
- OB
- Submission Type