510(k) K883283
K883283 is an FDA 510(k) premarket notification submitted by Galenica Enterprises, Inc. for the device "DISPOSABLE AMNIOTOME". The FDA issued a decision of Substantially Equivalent on October 18, 1988. The device falls under product code HGG (Controller, Abortion Unit, Vacuum), a Class II device regulated under 21 CFR 884.5070. Galenica Enterprises, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 1988
- Date Received
- August 4, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Controller, Abortion Unit, Vacuum
- Device Class
- Class II
- Regulation Number
- 884.5070
- Review Panel
- OB
- Submission Type