GUARDIAN SAFE BOW

Headgear, Extraoral, Orthodontic

LANCER ORTHODONTICS, INC.

The following data is part of a premarket notification filed by Lancer Orthodontics, Inc. with the FDA for Guardian Safe Bow.

Pre-market Notification Details

• Device ID: K901958
• 510k Number: K901958
• Device Name: GUARDIAN SAFE BOW
• Classification: Headgear, Extraoral, Orthodontic
• Applicant: LANCER ORTHODONTICS, INC. 6050 AVENIDA ENCINAS P.O. BOX 819 Carlsbad, CA 92008
• Contact: Mike Ekinaka
• Correspondent: Mike Ekinaka; LANCER ORTHODONTICS, INC. 6050 AVENIDA ENCINAS P.O. BOX 819 Carlsbad, CA 92008
• Product Code: DZB
• CFR Regulation Number: 872.5500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-05-01
• Decision Date: 1990-07-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817573023684	K901958	000
00817573023851	K901958	000
00817573023868	K901958	000
00817573023875	K901958	000
00817573023882	K901958	000
00817573023899	K901958	000
00817573023905	K901958	000
00817573023912	K901958	000
00817573023929	K901958	000
00817573023936	K901958	000
00817573023943	K901958	000
00817573023950	K901958	000
00817573023967	K901958	000
00817573023974	K901958	000
00817573023981	K901958	000
00817573023844	K901958	000
00817573023837	K901958	000
00817573023691	K901958	000
00817573023707	K901958	000
00817573023714	K901958	000
00817573023721	K901958	000
00817573023738	K901958	000
00817573023745	K901958	000
00817573023752	K901958	000
00817573023769	K901958	000
00817573023776	K901958	000
00817573023783	K901958	000
00817573023790	K901958	000
00817573023806	K901958	000
00817573023813	K901958	000
00817573023820	K901958	000
00817573023998	K901958	000
00817573024001	K901958	000
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00817573024186	K901958	000
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00817573024223	K901958	000
00817573024230	K901958	000
00817573024247	K901958	000
00817573024254	K901958	000
00817573024261	K901958	000
00817573024278	K901958	000
00817573024285	K901958	000
00817573024292	K901958	000
00817573024308	K901958	000
00817573024315	K901958	000
00817573024179	K901958	000
00817573024162	K901958	000
00817573024025	K901958	000
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00817573024049	K901958	000
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00817573024087	K901958	000
00817573024094	K901958	000
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00817573024117	K901958	000
00817573024124	K901958	000
00817573024131	K901958	000
00817573024148	K901958	000
00817573024155	K901958	000
00817573024322	K901958	000