510(k) K973379

STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS by S. Jackson, Inc. — Product Code FTM

K973379 is an FDA 510(k) premarket notification submitted by S. Jackson, Inc. for the device "STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS". The FDA issued a decision of Substantially Equivalent on September 25, 1997. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. S. Jackson, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1997
Date Received
September 8, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type