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FDA 510(k)

PROPHYLACTIC (CONDOM) MR. JOHNNY

K-Number: K865106 · 1987-05-20

ApplicantMedelec Intl. Corp.
Decision Date1987-05-20
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PROPHYLACTIC (CONDOM) MR. JOHNNY is the device name listed in this FDA 510(k) record. The listed applicant is Medelec Intl. Corp.. It received FDA 510(k) clearance on 1987-05-20 under 510(k) number K865106. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROPHYLACTIC (CONDOM) MR. JOHNNY?

PROPHYLACTIC (CONDOM) MR. JOHNNY is a medical device that received FDA 510(k) clearance on 1987-05-20. The listed applicant is Medelec Intl. Corp.. The 510(k) number is K865106.

When did PROPHYLACTIC (CONDOM) MR. JOHNNY receive FDA 510(k) clearance?

PROPHYLACTIC (CONDOM) MR. JOHNNY received FDA 510(k) clearance on 1987-05-20, under 510(k) number K865106.

Who is the listed applicant for PROPHYLACTIC (CONDOM) MR. JOHNNY?

The FDA 510(k) record lists Medelec Intl. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROPHYLACTIC (CONDOM) MR. JOHNNY?

The FDA product code for PROPHYLACTIC (CONDOM) MR. JOHNNY is HIS.

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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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