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FDA 510(k)

0.2 U BACTERIAL FILTER

K-Number: K974661 · 1998-02-11

ApplicantSims Deltec, Inc.
Decision Date1998-02-11
Product CodeFPB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

0.2 U BACTERIAL FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Sims Deltec, Inc.. It received FDA 510(k) clearance on 1998-02-11 under 510(k) number K974661. The device is classified under product code FPB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 0.2 U BACTERIAL FILTER?

0.2 U BACTERIAL FILTER is a medical device that received FDA 510(k) clearance on 1998-02-11. The listed applicant is Sims Deltec, Inc.. The 510(k) number is K974661.

When did 0.2 U BACTERIAL FILTER receive FDA 510(k) clearance?

0.2 U BACTERIAL FILTER received FDA 510(k) clearance on 1998-02-11, under 510(k) number K974661.

Who is the listed applicant for 0.2 U BACTERIAL FILTER?

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

What is the FDA product code for 0.2 U BACTERIAL FILTER?

The FDA product code for 0.2 U BACTERIAL FILTER is FPB.

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Other records listing Sims Deltec, Inc. as applicant

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Related Devices (Code: FPB)

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.

K261403Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion FilterGlobal Life Sciences Solutions USA, LLCK233277Filter Needle for Single UseHangzhou Qiantang Longyue Biotechnology Co., Ltd.K113227NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTERBaxter Healthcare CorpK021293ARTERIA BLOOD FILTERArteria Medical Science, Inc.K993379PALL SUPOR AEF FILTERPall Corp.K964283AUTOPRIMEArbor Technologies, Inc.

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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