510(k) K811568
K811568 is an FDA 510(k) premarket notification submitted by Gynemetrics, Inc. for the device "CERVICAL DILATOR". The FDA issued a decision of Substantially Equivalent on July 16, 1981. The device falls under product code HDQ (Dilator, Cervical, Fixed Size), a Class I device regulated under 21 CFR 884.4530. Gynemetrics, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 1981
- Date Received
- June 4, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Cervical, Fixed Size
- Device Class
- Class I
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type