510(k) K852679

MULTIPLE(HEMORX) IF APPROVED BY TRADEMARK OFFICE by J. & Jp., Inc. — Product Code LKX

K852679 is an FDA 510(k) premarket notification submitted by J. & Jp., Inc. for the device "MULTIPLE(HEMORX) IF APPROVED BY TRADEMARK OFFICE". The FDA issued a decision of Substantially Equivalent on August 9, 1985. The device falls under product code LKX (Device, Thermal, Hemorrhoids), a Class U device. J. & Jp., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1985
Date Received
June 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Thermal, Hemorrhoids
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type