Cleared Traditional

BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED

K933232 · Boehringer Laboratories · General Hospital
Mar 1994
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K933232 is an FDA 510(k) clearance for the BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED, a Regulator, Vacuum (Class II — Special Controls, product code KDP), submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on March 28, 1994, 265 days after receiving the submission on July 6, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K933232 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 1993
Decision Date March 28, 1994
Days to Decision 265 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code KDP — Regulator, Vacuum
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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