CONDOM SEAL— 510(k) K903715

Substantially Equivalent

Mark Sullivan, M.D., P.C.

FDA 510(k) clearance K903715 for CONDOM SEAL, Substantially Equivalent on 1991-01-23. Applicant: Mark Sullivan, M.D., P.C.. Device class: 1.

Clearance details

Applicant: Mark Sullivan, M.D., P.C.
Product code: Code EXJ
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1990-08-14
Decision date: 1991-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mission Viejo, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EXJ

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K962900 — SELF RETAINING MALE EXTERNAL URINARY CATHETER1996-09-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.