510(k) K951148
K951148 is an FDA 510(k) premarket notification submitted by Onli for the device "OBSTI-HOOK". The FDA issued a decision of Substantially Equivalent on June 9, 1995. The device falls under product code HGE (Amniotome), a Class I device regulated under 21 CFR 884.4530.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 1995
- Date Received
- March 13, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Amniotome
- Device Class
- Class I
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type