510(k) K820302

SURGIPEEL SELF-SEAL PACKAGING SYSTEM by Surgicot, Inc. — Product Code FRG

K820302 is an FDA 510(k) premarket notification submitted by Surgicot, Inc. for the device "SURGIPEEL SELF-SEAL PACKAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on February 24, 1982. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Surgicot, Inc. has at least 10 other 510(k) clearances on record.