510(k) K980976

AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP by Hollister, Inc. — Product Code HDB

K980976 is an FDA 510(k) premarket notification submitted by Hollister, Inc. for the device "AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP". The FDA issued a decision of Substantially Equivalent on August 21, 1998. The device falls under product code HDB (Extractor, Vacuum, Fetal), a Class II device regulated under 21 CFR 884.4340. Hollister, Inc. has at least 10 other 510(k) clearances on record.