510(k) K926349
K926349 is an FDA 510(k) premarket notification submitted by Life-Tech Intl., Inc. for the device "PROBLOC INSULATED NEEDLES". The FDA issued a decision of Substantially Equivalent on July 29, 1993. The device falls under product code GXZ (Electrode, Needle), a Class II device regulated under 21 CFR 882.1350. Life-Tech Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 29, 1993
- Date Received
- December 17, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Needle
- Device Class
- Class II
- Regulation Number
- 882.1350
- Review Panel
- NE
- Submission Type