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FDA 510(k)

RESPONSE EXTERNAL PENILE RIGIDITY DEVICE

K-Number: K900559 · 1990-05-02

ApplicantSmith-Collins Pharmaceutical, Inc.
Decision Date1990-05-02
Product CodeLKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RESPONSE EXTERNAL PENILE RIGIDITY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Smith-Collins Pharmaceutical, Inc.. It received FDA 510(k) clearance on 1990-05-02 under 510(k) number K900559. The device is classified under product code LKY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPONSE EXTERNAL PENILE RIGIDITY DEVICE?

RESPONSE EXTERNAL PENILE RIGIDITY DEVICE is a medical device that received FDA 510(k) clearance on 1990-05-02. The listed applicant is Smith-Collins Pharmaceutical, Inc.. The 510(k) number is K900559.

When did RESPONSE EXTERNAL PENILE RIGIDITY DEVICE receive FDA 510(k) clearance?

RESPONSE EXTERNAL PENILE RIGIDITY DEVICE received FDA 510(k) clearance on 1990-05-02, under 510(k) number K900559.

Who is the listed applicant for RESPONSE EXTERNAL PENILE RIGIDITY DEVICE?

The FDA 510(k) record lists Smith-Collins Pharmaceutical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESPONSE EXTERNAL PENILE RIGIDITY DEVICE?

The FDA product code for RESPONSE EXTERNAL PENILE RIGIDITY DEVICE is LKY.

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Related Devices (Code: LKY)

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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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