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FDA 510(k)

PROPHYLACTIC (CONDOM)

K-Number: K854622 · 1986-04-11

ApplicantMedelec Intl. Corp.
Decision Date1986-04-11
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PROPHYLACTIC (CONDOM) 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 1986-04-11 under 510(k) number K854622. 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)?

PROPHYLACTIC (CONDOM) is a medical device that received FDA 510(k) clearance on 1986-04-11. The listed applicant is Medelec Intl. Corp.. The 510(k) number is K854622.

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

PROPHYLACTIC (CONDOM) received FDA 510(k) clearance on 1986-04-11, under 510(k) number K854622.

Who is the listed applicant for PROPHYLACTIC (CONDOM)?

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)?

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

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Other records listing Medelec Intl. Corp. as applicant

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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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