SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004

Indicator, Physical/chemical Sterilization Process

SPS MEDICAL SUPPLY CORP.

The following data is part of a premarket notification filed by Sps Medical Supply Corp. with the FDA for Spsmedical Emplus 270 F Steam Emulator Model Emp-104, Emp-1004.

Pre-market Notification Details

• Device ID: K102363
• 510k Number: K102363
• Device Name: SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004
• Classification: Indicator, Physical/chemical Sterilization Process
• Applicant: SPS MEDICAL SUPPLY CORP. 6789 WEST HENRIETTA RD. Rush, NY 14543
• Contact: Gary J Socola
• Correspondent: Gary J Socola; SPS MEDICAL SUPPLY CORP. 6789 WEST HENRIETTA RD. Rush, NY 14543
• Product Code: JOJ
• CFR Regulation Number: 880.2800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-08-20
• Decision Date: 2011-01-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10732224710744	K102363	000
10732224710737	K102363	000