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FDA 510(k)

SILENT GUARD CAT. NO. SG-10

K-Number: K873488 · 1987-10-07

ApplicantAmerican Omni Medical, Inc.
Decision Date1987-10-07
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SILENT GUARD CAT. NO. SG-10 is the device name listed in this FDA 510(k) record. The listed applicant is American Omni Medical, Inc.. It received FDA 510(k) clearance on 1987-10-07 under 510(k) number K873488. The device is classified under product code DTL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILENT GUARD CAT. NO. SG-10?

SILENT GUARD CAT. NO. SG-10 is a medical device that received FDA 510(k) clearance on 1987-10-07. The listed applicant is American Omni Medical, Inc.. The 510(k) number is K873488.

When did SILENT GUARD CAT. NO. SG-10 receive FDA 510(k) clearance?

SILENT GUARD CAT. NO. SG-10 received FDA 510(k) clearance on 1987-10-07, under 510(k) number K873488.

Who is the listed applicant for SILENT GUARD CAT. NO. SG-10?

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

What is the FDA product code for SILENT GUARD CAT. NO. SG-10?

The FDA product code for SILENT GUARD CAT. NO. SG-10 is DTL.

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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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