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FDA 510(k)

AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP

K-Number: K980976 · 1998-08-21

ApplicantHollister, Inc.
Decision Date1998-08-21
Product CodeHDB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP is the device name listed in this FDA 510(k) record. The listed applicant is Hollister, Inc.. It received FDA 510(k) clearance on 1998-08-21 under 510(k) number K980976. The device is classified under product code HDB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP?

AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP is a medical device that received FDA 510(k) clearance on 1998-08-21. The listed applicant is Hollister, Inc.. The 510(k) number is K980976.

When did AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP receive FDA 510(k) clearance?

AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP received FDA 510(k) clearance on 1998-08-21, under 510(k) number K980976.

Who is the listed applicant for AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP?

The FDA 510(k) record lists Hollister, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP?

The FDA product code for AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP is HDB.

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Related Devices (Code: HDB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250298Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)Clinical Innovations, LLCK041579MEDELA SINGLE USE SILC CUP, MODEL 077.0791Medela AGK043614VACULINK, MODEL VCL 3000Medevco, Inc.K021193FORTUNE SILICONE VACUUM SUCTION, MODEL #1300Fortune Medical Instrument Corp.K020447MITYVAC MERLIN, MODEL 10027Prism Enterprises, Inc.K013460SWIFT LOW PROFILE CUP (PRO CUP)Swift Delivery Products

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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