510(k) K852956
K852956 is an FDA 510(k) premarket notification submitted by Parker Laboratories, Inc. for the device "CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION". The FDA issued a decision of Substantially Equivalent on August 9, 1985. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275. Parker Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 9, 1985
- Date Received
- July 11, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Electroconductive
- Device Class
- Class II
- Regulation Number
- 882.1275
- Review Panel
- NE
- Submission Type