510(k) K832137

CONVERTORS FLASH STERILIZING TRAY by American Convertors Div., American Pharmaseal — Product Code FSM

K832137 is an FDA 510(k) premarket notification submitted by American Convertors Div., American Pharmaseal for the device "CONVERTORS FLASH STERILIZING TRAY". The FDA issued a decision of Substantially Equivalent on August 12, 1983. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. American Convertors Div., American Pharmaseal has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1983
Date Received
July 1, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Surgical, Instrument
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type