LAMINARIA— 510(k) K881312

Substantially Equivalent

Busse Hospital Disposables, Inc.

FDA 510(k) clearance K881312 for LAMINARIA, Substantially Equivalent on 1988-05-23. Applicant: Busse Hospital Disposables, Inc.. Device class: 2.

Clearance details

Applicant: Busse Hospital Disposables, Inc.
Product code: Code HDY
Device class: Class 2
Regulation: 21 CFR 884.4260
Advisory panel: Obstetrics/Gynecology
Date received: 1988-03-28
Decision date: 1988-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HDY

K040625 — ATAD ARD CATHETER2005-01-18
K021012 — LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM2002-06-25
K011512 — MMODIFICATION TO LAMINARIA2001-07-09
K955072 — LAMINARIA1996-05-22
K892220 — LAMINARIA TENT1989-06-14

More clearances from Busse Hospital Disposables, Inc.

K120002 — I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE2012-06-26
K093909 — BUSSE SURGICAL DRAPES IV2010-05-06
K092212 — BUSSE SURGICAL DRAPES III2009-10-09
K082297 — BUSSE SURGICAL DRAPE2008-12-09
K073222 — MODIFICATION TO:SPECIALTY NEEDLES2008-04-09

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