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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tent, Oxygen
510(k) Number K893713
Device Name NOVA OXYGEN TENT
Applicant
Nova Health Systems, Inc.
1001 Lower Landing Rd.
Suite 409
Blackwood,  NJ  08012
Applicant Contact ROBERT DELANO
Correspondent
Nova Health Systems, Inc.
1001 Lower Landing Rd.
Suite 409
Blackwood,  NJ  08012
Correspondent Contact ROBERT DELANO
Regulation Number868.5700
Classification Product Code
BYL  
Date Received05/18/1989
Decision Date 08/21/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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