510(k) K902516
K902516 is an FDA 510(k) premarket notification submitted by Sims Surgical, Inc. for the device "NEW LENGTH SUGITA APPLIERS". The FDA issued a decision of Substantially Equivalent on July 3, 1990. The device falls under product code HIC (Speculum, Vaginal, Nonmetal, Fiberoptic), a Class II device regulated under 21 CFR 884.4530. Sims Surgical, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 1990
- Date Received
- June 7, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Speculum, Vaginal, Nonmetal, Fiberoptic
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type