Who is the manufacturer of SUR-FIT SYSTEM PRE-OPERATION SET?

E. R. Squibb & Sons, Inc. filed the 510(k) submission for SUR-FIT SYSTEM PRE-OPERATION SET (K801702).

What is the FDA product code for SUR-FIT SYSTEM PRE-OPERATION SET?

EXB. It is classified under 21 CFR 876.5900 as a Class 1 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for SUR-FIT SYSTEM PRE-OPERATION SET?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SUR-FIT SYSTEM PRE-OPERATION SET?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SUR-FIT SYSTEM PRE-OPERATION SET

K801702 · E. R. Squibb & Sons, Inc. · EXB · Aug 27, 1980 · Gastroenterology, Urology

Device Facts

Record ID	K801702
Device Name	SUR-FIT SYSTEM PRE-OPERATION SET
Applicant	E. R. Squibb & Sons, Inc.
Product Code	EXB · Gastroenterology, Urology
Decision Date	Aug 27, 1980
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5900
Device Class	Class 1

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