MARLOW ANAL SPECULUM— 510(k) K891352

Substantially Equivalent

Simpson/Basye, Inc.

FDA 510(k) clearance K891352 for MARLOW ANAL SPECULUM, Substantially Equivalent on 1989-06-23. Applicant: Simpson/Basye, Inc.. Device class: 1.

Clearance details

Applicant: Simpson/Basye, Inc.
Product code: Code KOA
Device class: Class 1
Regulation: 21 CFR 876.4730
Advisory panel: Gastroenterology, Urology
Date received: 1989-03-10
Decision date: 1989-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

Download summary PDF View on FDA.gov ↗

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More clearances from Simpson/Basye, Inc.

K926179 — SEDLACEK HANDLE1994-03-25
K891351 — NEWPORT LATERAL VAGINAL RETRACTOR1989-05-11
K891347 — REID ENDOCERVICAL SPREADER1989-03-29
K891349 — CAMPION CERVICAL HOOK1989-03-29
K891350 — NEWPORT CERVICAL MANIPULATOR1989-03-29

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