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FDA 510(k)

SHARPS COLLECTION CONTAINER - SAF-T-SHELL

K-Number: K982029 · 1999-04-06

ApplicantAmerican Medical Mfg., Inc.
Decision Date1999-04-06
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SHARPS COLLECTION CONTAINER - SAF-T-SHELL is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Mfg., Inc.. It received FDA 510(k) clearance on 1999-04-06 under 510(k) number K982029. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHARPS COLLECTION CONTAINER - SAF-T-SHELL?

SHARPS COLLECTION CONTAINER - SAF-T-SHELL is a medical device that received FDA 510(k) clearance on 1999-04-06. The listed applicant is American Medical Mfg., Inc.. The 510(k) number is K982029.

When did SHARPS COLLECTION CONTAINER - SAF-T-SHELL receive FDA 510(k) clearance?

SHARPS COLLECTION CONTAINER - SAF-T-SHELL received FDA 510(k) clearance on 1999-04-06, under 510(k) number K982029.

Who is the listed applicant for SHARPS COLLECTION CONTAINER - SAF-T-SHELL?

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

What is the FDA product code for SHARPS COLLECTION CONTAINER - SAF-T-SHELL?

The FDA product code for SHARPS COLLECTION CONTAINER - SAF-T-SHELL is FMI.

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Other records listing American Medical Mfg., Inc. as applicant

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Related Devices (Code: FMI)

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

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