510(k) K881730
K881730 is an FDA 510(k) premarket notification submitted by Hart Enterprises, Inc. for the device "BREAST LOCALIZATION NEEDLES". The FDA issued a decision of Substantially Equivalent on May 13, 1988. The device falls under product code GDM (Needle, Aspiration And Injection, Reusable), a Class I device regulated under 21 CFR 878.4800. Hart Enterprises, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 1988
- Date Received
- April 22, 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