510(k) K982067

MAGNETIC PORT SILICONE TISSUE EXPANDER by Specialty Surgical Products, Inc. — Product Code LCJ

K982067 is an FDA 510(k) premarket notification submitted by Specialty Surgical Products, Inc. for the device "MAGNETIC PORT SILICONE TISSUE EXPANDER". The FDA issued a decision of Substantially Equivalent on July 13, 1998. The device falls under product code LCJ (Tissue Expander And Accessories), a Class U device. Specialty Surgical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1998
Date Received
June 12, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tissue Expander And Accessories
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type