CONCEPTROL/THIN PROPHYLACTICS— 510(k) K792634

Name: FDA 510(k) clearance K792634
Creator: U.S. Food and Drug Administration
Published: 1980-01-16

Substantially Equivalent

Ortho Pharmaceutical Corp.

FDA 510(k) clearance K792634 for CONCEPTROL/THIN PROPHYLACTICS, Substantially Equivalent on 1980-01-16. Applicant: Ortho Pharmaceutical Corp.. Device class: 2.

Clearance details

Applicant: Ortho Pharmaceutical Corp.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1979-12-19
Decision date: 1980-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ortho Pharmaceutical Corp.

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K955648 — K-Y PERSONAL LUBRICANT1996-06-21
K934516 — ADVANCE PREGNANCY TEST MODIFICATION1994-02-24
K914990 — ADVANCE(R) PREGNANCY TEST1991-12-23
K893488 — PULSATILE PUMP FOR GONADORELIN ACETATE1989-10-31
K881151 — MICROSCRAPE1988-04-06

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