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FDA 510(k)

AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR

K-Number: K895700 · 1990-04-02

ApplicantHollister, Inc.
Decision Date1990-04-02
Product CodeHDB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Hollister, Inc.. It received FDA 510(k) clearance on 1990-04-02 under 510(k) number K895700. 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/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR?

AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR is a medical device that received FDA 510(k) clearance on 1990-04-02. The listed applicant is Hollister, Inc.. The 510(k) number is K895700.

When did AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR receive FDA 510(k) clearance?

AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR received FDA 510(k) clearance on 1990-04-02, under 510(k) number K895700.

Who is the listed applicant for AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR?

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/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR?

The FDA product code for AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR 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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