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FDA 510(k)

AB VACUUM EXTRACTOR SILC-CUP

K-Number: K841492 · 1984-05-07

ApplicantMedela, Inc.
Decision Date1984-05-07
Product CodeHDB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AB VACUUM EXTRACTOR SILC-CUP is the device name listed in this FDA 510(k) record. The listed applicant is Medela, Inc.. It received FDA 510(k) clearance on 1984-05-07 under 510(k) number K841492. 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 AB VACUUM EXTRACTOR SILC-CUP?

AB VACUUM EXTRACTOR SILC-CUP is a medical device that received FDA 510(k) clearance on 1984-05-07. The listed applicant is Medela, Inc.. The 510(k) number is K841492.

When did AB VACUUM EXTRACTOR SILC-CUP receive FDA 510(k) clearance?

AB VACUUM EXTRACTOR SILC-CUP received FDA 510(k) clearance on 1984-05-07, under 510(k) number K841492.

Who is the listed applicant for AB VACUUM EXTRACTOR SILC-CUP?

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

What is the FDA product code for AB VACUUM EXTRACTOR SILC-CUP?

The FDA product code for AB VACUUM EXTRACTOR SILC-CUP is HDB.

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Other records listing Medela, Inc. as applicant

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.

K161811Medela Low Dose Enteral SyringeK161725Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retailK031614MEDELA PUMP IN STYLE ADVANCED BREAST PUMPK020518MEDELA SYMPHONY BREAST PUMP, MODEL 024K984589PHOTOTHERAPY LAMPK983552BASIC, MEDIAN, DOMINANT, AND VARIO

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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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