Cleared Traditional

K960663 - UNIVERSAL BITE BLOCK
(FDA 510(k) Clearance)

K960663 · B&B Medical Technologies, Inc. · Neurology

May 1996

Decision

91d

Days

Class 2

Risk

K960663 is an FDA 510(k) clearance for the UNIVERSAL BITE BLOCK, a Block, Bite (Class II — Special Controls, product code JXL), submitted by B&B Medical Technologies, Inc. (Orangevale, US). The FDA issued a Cleared decision on May 17, 1996, 91 days after receiving the submission on February 16, 1996. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5070.

Submission Details

510(k) Number	K960663 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 16, 1996
Decision Date	May 17, 1996
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Statement