510(k) K010835

POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385 by Busse Hospital Disposables, Inc. — Product Code HFW

K010835 is an FDA 510(k) premarket notification submitted by Busse Hospital Disposables, Inc. for the device "POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385". The FDA issued a decision of Substantially Equivalent on April 30, 2001. The device falls under product code HFW (Clamp, Umbilical), a Class II device regulated under 21 CFR 884.4530. Busse Hospital Disposables, Inc. has at least 10 other 510(k) clearances on record.