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FDA 510(k)

SARGON IMMEDIATE LOAD IMPLANT, MODEL D

K-Number: K981141 · 1999-06-23

Decision Date1999-06-23
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SARGON IMMEDIATE LOAD IMPLANT, MODEL D is the device name listed in this FDA 510(k) record. The listed applicant is Sargon Ent., Inc.. It received FDA 510(k) clearance on 1999-06-23 under 510(k) number K981141. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SARGON IMMEDIATE LOAD IMPLANT, MODEL D?

SARGON IMMEDIATE LOAD IMPLANT, MODEL D is a medical device that received FDA 510(k) clearance on 1999-06-23. The listed applicant is Sargon Ent., Inc.. The 510(k) number is K981141.

When did SARGON IMMEDIATE LOAD IMPLANT, MODEL D receive FDA 510(k) clearance?

SARGON IMMEDIATE LOAD IMPLANT, MODEL D received FDA 510(k) clearance on 1999-06-23, under 510(k) number K981141.

Who is the listed applicant for SARGON IMMEDIATE LOAD IMPLANT, MODEL D?

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

What is the FDA product code for SARGON IMMEDIATE LOAD IMPLANT, MODEL D?

The FDA product code for SARGON IMMEDIATE LOAD IMPLANT, MODEL D is DZE.

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.

Other records listing Sargon Ent., 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.

Related Devices (Code: DZE)

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.

Official Source

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