510(k) K022099

SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S by Hdc Corp. — Product Code FOZ

K022099 is an FDA 510(k) premarket notification submitted by Hdc Corp. for the device "SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S". The FDA issued a decision of Substantially Equivalent on September 20, 2002. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Hdc Corp. has at least 10 other 510(k) clearances on record.