The following data is part of a premarket notification filed by N.m. Beale Co. Inc. with the FDA for N. M. Beale Company Vu-thru Water Bottle.
Device ID | K903834 |
510k Number | K903834 |
Device Name: | N. M. BEALE COMPANY VU-THRU WATER BOTTLE |
Classification | Endoscopic Irrigation/suction System |
Applicant | N.M. BEALE CO. INC. 26 TWILIGHT PATH Weymouth, MA 02189 |
Contact | Nathanel Beale |
Correspondent | Nathanel Beale N.M. BEALE CO. INC. 26 TWILIGHT PATH Weymouth, MA 02189 |
Product Code | OCX |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-21 |
Decision Date | 1990-09-24 |