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FDA 510(k)

BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC

K-Number: K081547 · 2008-09-08

ApplicantBio-Med USA, Inc.
Decision Date2008-09-08
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Med USA, Inc.. It received FDA 510(k) clearance on 2008-09-08 under 510(k) number K081547. 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 BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC?

BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC is a medical device that received FDA 510(k) clearance on 2008-09-08. The listed applicant is Bio-Med USA, Inc.. The 510(k) number is K081547.

When did BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC receive FDA 510(k) clearance?

BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC received FDA 510(k) clearance on 2008-09-08, under 510(k) number K081547.

Who is the listed applicant for BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC?

The FDA 510(k) record lists Bio-Med USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC?

The FDA product code for BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC is FMF.

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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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