INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL

Forceps, Surgical, Gynecological

INSTRUMED INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Instrumed International, Inc. with the FDA for Instrumed Forceps Obstetrical/gynaecological.

Pre-market Notification Details

• Device ID: K092840
• 510k Number: K092840
• Device Name: INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL
• Classification: Forceps, Surgical, Gynecological
• Applicant: INSTRUMED INTERNATIONAL, INC. 626 COOPER COURT Schaumburg, IL 60173
• Contact: Michael Massong
• Correspondent: Michael Massong; INSTRUMED INTERNATIONAL, INC. 626 COOPER COURT Schaumburg, IL 60173
• Product Code: HCZ
• CFR Regulation Number: 884.4530 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-09-15
• Decision Date: 2009-12-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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