510(k) K881295
K881295 is an FDA 510(k) premarket notification submitted by Harold W. Berger Co. for the device "LAMINARIA CUREX". The FDA issued a decision of Substantially Equivalent on Aug 10, 1988. The device falls under product code HDY (Dilator, Cervical, Hygroscopic-Laminaria), a Class II device regulated under 21 CFR 884.4260.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 10, 1988
- Date Received
- Mar 28, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Dilator, Cervical, Hygroscopic-Laminaria
- Device Class
- Class II
- Regulation Number
- 884.4260
- Review Panel
- OB
- Submission Type
- 510(k)