Cleared Traditional

NON-REBREATHING TEE PIECE (NRTP)

K883988 · Dhd Medical Products Div. Diemolding Corp. · Anesthesiology
Oct 1988
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K883988 is an FDA 510(k) clearance for the NON-REBREATHING TEE PIECE (NRTP), a Valve, Non-rebreathing (Class II — Special Controls, product code CBP), submitted by Dhd Medical Products Div. Diemolding Corp. (Canastota, US). The FDA issued a Cleared decision on October 7, 1988, 17 days after receiving the submission on September 20, 1988. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5870.

Submission Details

510(k) Number K883988 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 1988
Decision Date October 07, 1988
Days to Decision 17 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CBP — Valve, Non-rebreathing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5870

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