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FDA 510(k)

SR-IVOLEN

K-Number: K810686 · 1981-04-14

ApplicantJ. Aderer, Inc.
Decision Date1981-04-14
Product CodeEBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SR-IVOLEN is the device name listed in this FDA 510(k) record. The listed applicant is J. Aderer, Inc.. It received FDA 510(k) clearance on 1981-04-14 under 510(k) number K810686. The device is classified under product code EBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SR-IVOLEN?

SR-IVOLEN is a medical device that received FDA 510(k) clearance on 1981-04-14. The listed applicant is J. Aderer, Inc.. The 510(k) number is K810686.

When did SR-IVOLEN receive FDA 510(k) clearance?

SR-IVOLEN received FDA 510(k) clearance on 1981-04-14, under 510(k) number K810686.

Who is the listed applicant for SR-IVOLEN?

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

What is the FDA product code for SR-IVOLEN?

The FDA product code for SR-IVOLEN is EBH.

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Other records listing J. Aderer, 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.

K822956G CASTK822957PURCASTK82179882 ALLOYK821832DEGUCAST UK821572DUALLOR 'R'K821590PORS-ON

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Related Devices (Code: EBH)

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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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