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FDA 510(k)

SOLITENS MODIFIED

K-Number: K913522 · 1991-08-28

ApplicantInnovative Designer Products, Inc.
Decision Date1991-08-28
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SOLITENS MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Designer Products, Inc.. It received FDA 510(k) clearance on 1991-08-28 under 510(k) number K913522. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLITENS MODIFIED?

SOLITENS MODIFIED is a medical device that received FDA 510(k) clearance on 1991-08-28. The listed applicant is Innovative Designer Products, Inc.. The 510(k) number is K913522.

When did SOLITENS MODIFIED receive FDA 510(k) clearance?

SOLITENS MODIFIED received FDA 510(k) clearance on 1991-08-28, under 510(k) number K913522.

Who is the listed applicant for SOLITENS MODIFIED?

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

What is the FDA product code for SOLITENS MODIFIED?

The FDA product code for SOLITENS MODIFIED is GZJ.

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Related Devices (Code: GZJ)

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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