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FDA 510(k)

STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS)

K-Number: K910778 · 1991-10-28

ApplicantMdt Biologic Co.
Decision Date1991-10-28
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS) is the device name listed in this FDA 510(k) record. The listed applicant is Mdt Biologic Co.. It received FDA 510(k) clearance on 1991-10-28 under 510(k) number K910778. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS)?

STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS) is a medical device that received FDA 510(k) clearance on 1991-10-28. The listed applicant is Mdt Biologic Co.. The 510(k) number is K910778.

When did STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS) receive FDA 510(k) clearance?

STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS) received FDA 510(k) clearance on 1991-10-28, under 510(k) number K910778.

Who is the listed applicant for STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS)?

The FDA 510(k) record lists Mdt Biologic Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS)?

The FDA product code for STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS) is FLE.

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Other records listing Mdt Biologic Co. 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.

K954736ACCESS (POWERCLAVE)K954940MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLEK943654HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERSK911087CASTLE WASHER/DISINFECTOR, MODEL 7550K910777MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZERK910649MDT/CASTLE 10/90 LOAD STATION

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Related Devices (Code: FLE)

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.

K261055AMSCO 700 Steam SterilizerSTERIS CorporationK260254Enbio PROEnbio Group AGK252307Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company)K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas LifecareK250164Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd.K243994Steam Sterilizer (2545D)Ningbo Ican Machines Co., Ltd.

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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