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FDA 510(k)

THE ON-GARD RECAPPER

K-Number: K895220 · 1989-11-08

ApplicantOn-Gard Systems, Inc.
Decision Date1989-11-08
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THE ON-GARD RECAPPER is the device name listed in this FDA 510(k) record. The listed applicant is On-Gard Systems, Inc.. It received FDA 510(k) clearance on 1989-11-08 under 510(k) number K895220. 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 THE ON-GARD RECAPPER?

THE ON-GARD RECAPPER is a medical device that received FDA 510(k) clearance on 1989-11-08. The listed applicant is On-Gard Systems, Inc.. The 510(k) number is K895220.

When did THE ON-GARD RECAPPER receive FDA 510(k) clearance?

THE ON-GARD RECAPPER received FDA 510(k) clearance on 1989-11-08, under 510(k) number K895220.

Who is the listed applicant for THE ON-GARD RECAPPER?

The FDA 510(k) record lists On-Gard Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE ON-GARD RECAPPER?

The FDA product code for THE ON-GARD RECAPPER is FMF.

Related Clinical Trials

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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Other records listing On-Gard Systems, 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.

K903855THE ON-GARD CORD-CADDY

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

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