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FDA 510(k)

MARSAM MODEL 2000 NEBULIZER

K-Number: K933961 · 1995-09-19

ApplicantMarsam Pharmaceuticals, Inc.
Decision Date1995-09-19
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MARSAM MODEL 2000 NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Marsam Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1995-09-19 under 510(k) number K933961. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARSAM MODEL 2000 NEBULIZER?

MARSAM MODEL 2000 NEBULIZER is a medical device that received FDA 510(k) clearance on 1995-09-19. The listed applicant is Marsam Pharmaceuticals, Inc.. The 510(k) number is K933961.

When did MARSAM MODEL 2000 NEBULIZER receive FDA 510(k) clearance?

MARSAM MODEL 2000 NEBULIZER received FDA 510(k) clearance on 1995-09-19, under 510(k) number K933961.

Who is the listed applicant for MARSAM MODEL 2000 NEBULIZER?

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

What is the FDA product code for MARSAM MODEL 2000 NEBULIZER?

The FDA product code for MARSAM MODEL 2000 NEBULIZER is CAF.

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Official Source

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