510(k) K952729

PAINTED WEDGE & ROD BREAST BOARD by Medtec, Inc. — Product Code IYE

K952729 is an FDA 510(k) premarket notification submitted by Medtec, Inc. for the device "PAINTED WEDGE & ROD BREAST BOARD". The FDA issued a decision of Substantially Equivalent on September 15, 1995. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Medtec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1995
Date Received
June 15, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type