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FDA 510(k)

DECOMAT 4656

K-Number: K950566 · 1995-10-19

ApplicantGetinge Disinfection, Inc.
Decision Date1995-10-19
Product CodeLDS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DECOMAT 4656 is the device name listed in this FDA 510(k) record. The listed applicant is Getinge Disinfection, Inc.. It received FDA 510(k) clearance on 1995-10-19 under 510(k) number K950566. The device is classified under product code LDS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DECOMAT 4656?

DECOMAT 4656 is a medical device that received FDA 510(k) clearance on 1995-10-19. The listed applicant is Getinge Disinfection, Inc.. The 510(k) number is K950566.

When did DECOMAT 4656 receive FDA 510(k) clearance?

DECOMAT 4656 received FDA 510(k) clearance on 1995-10-19, under 510(k) number K950566.

Who is the listed applicant for DECOMAT 4656?

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

What is the FDA product code for DECOMAT 4656?

The FDA product code for DECOMAT 4656 is LDS.

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Related Devices (Code: LDS)

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.

K183444Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level DisinfectorCenorin, LLCK031799MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881Miele, Inc.K983068RELIANCE FAMILY OF WASHER-DISINFECTORSSTERIS CorporationK972193OLYMPIX MINI-PASTEURMATIC (58210)Olympic Medical Corp.K950518MIELE G 7781 DENTAL THERMAL DISINFECTORMiele ProfessionalK953645OLYMPIC PASTEURMATIC SYSTEMOlympic Medical Corp.

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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