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FDA 510(k)

MITYVAC MERLIN, MODEL 10027

K-Number: K020447 · 2002-04-12

ApplicantPrism Enterprises, Inc.
Decision Date2002-04-12
Product CodeHDB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MITYVAC MERLIN, MODEL 10027 is the device name listed in this FDA 510(k) record. The listed applicant is Prism Enterprises, Inc.. It received FDA 510(k) clearance on 2002-04-12 under 510(k) number K020447. 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 MITYVAC MERLIN, MODEL 10027?

MITYVAC MERLIN, MODEL 10027 is a medical device that received FDA 510(k) clearance on 2002-04-12. The listed applicant is Prism Enterprises, Inc.. The 510(k) number is K020447.

When did MITYVAC MERLIN, MODEL 10027 receive FDA 510(k) clearance?

MITYVAC MERLIN, MODEL 10027 received FDA 510(k) clearance on 2002-04-12, under 510(k) number K020447.

Who is the listed applicant for MITYVAC MERLIN, MODEL 10027?

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

What is the FDA product code for MITYVAC MERLIN, MODEL 10027?

The FDA product code for MITYVAC MERLIN, MODEL 10027 is HDB.

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Other records listing Prism Enterprises, 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.

K030283BABY PODK011532MITYVACK000444MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM

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.K013460SWIFT LOW PROFILE CUP (PRO CUP)Swift Delivery ProductsK011532MITYVACPrism Enterprises, Inc.

Official Source

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

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