510(k) K001893

WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS) by White Knight Healthcare, Inc. — Product Code FXX

K001893 is an FDA 510(k) premarket notification submitted by White Knight Healthcare, Inc. for the device "WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS)". The FDA issued a decision of Substantially Equivalent on April 2, 2001. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. White Knight Healthcare, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2001
Date Received
June 21, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type