510(k) K853257
K853257 is an FDA 510(k) premarket notification submitted by Trylon Associates, Ltd. for the device "SPECULITE DISPOSABLE VAGINAL LIGHT". The FDA issued a decision of Substantially Equivalent on December 27, 1985. The device falls under product code HIC (Speculum, Vaginal, Nonmetal, Fiberoptic), a Class II device regulated under 21 CFR 884.4530.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 1985
- Date Received
- August 2, 1985
- 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