510(k) K850758
K850758 is an FDA 510(k) premarket notification submitted by Go Medical Industries Pty. , Ltd. for the device "AMNIGLOVE & AMNICOT". The FDA issued a decision of Substantially Equivalent on April 15, 1985. The device falls under product code HGE (Amniotome), a Class I device regulated under 21 CFR 884.4530. Go Medical Industries Pty. , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 15, 1985
- Date Received
- February 25, 1985
- 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