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FDA 510(k)

DRUG DISPENSING SPIKE

K-Number: K946190 · 1995-03-17

ApplicantGelman Sciences, Inc.
Decision Date1995-03-17
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DRUG DISPENSING SPIKE is the device name listed in this FDA 510(k) record. The listed applicant is Gelman Sciences, Inc.. It received FDA 510(k) clearance on 1995-03-17 under 510(k) number K946190. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRUG DISPENSING SPIKE?

DRUG DISPENSING SPIKE is a medical device that received FDA 510(k) clearance on 1995-03-17. The listed applicant is Gelman Sciences, Inc.. The 510(k) number is K946190.

When did DRUG DISPENSING SPIKE receive FDA 510(k) clearance?

DRUG DISPENSING SPIKE received FDA 510(k) clearance on 1995-03-17, under 510(k) number K946190.

Who is the listed applicant for DRUG DISPENSING SPIKE?

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

What is the FDA product code for DRUG DISPENSING SPIKE?

The FDA product code for DRUG DISPENSING SPIKE is FMF.

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Other records listing Gelman Sciences, 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.

K943127PHARMASSURE LARGE VOLUME TRANSFER FILTERSK941589SYRINGE FILTER DEVICESK941020DRUG RECONSTITUTION FILTER DEVICEK942275VIAL VENT FILTERK941032UNKNOWNK910821TRANSDUCER PROTECTOR

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Related Devices (Code: FMF)

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.

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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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