510(k) K885283
K885283 is an FDA 510(k) premarket notification submitted by Go Medical Industries Pty. , Ltd. for the device "ASPIRATING AND IRRIGATING CYSTS NEEDLES". The FDA issued a decision of Substantially Equivalent on March 22, 1989. The device falls under product code GDM (Needle, Aspiration And Injection, Reusable), a Class I device regulated under 21 CFR 878.4800. Go Medical Industries Pty. , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 1989
- Date Received
- December 20, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Aspiration And Injection, Reusable
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type