510(k) K951704

NON-WOVEN FILTER PAPER FOR STEAM AND GAS STERILIZATION by Products For Medicine — Product Code FRG

K951704 is an FDA 510(k) premarket notification submitted by Products For Medicine for the device "NON-WOVEN FILTER PAPER FOR STEAM AND GAS STERILIZATION". The FDA issued a decision of Substantially Equivalent on June 28, 1995. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Products For Medicine has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1995
Date Received
April 12, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type