DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)

Holder, Head, Neurosurgical (skull Clamp)

PRO-MED INSTRUMENTS GMBH

The following data is part of a premarket notification filed by Pro-med Instruments Gmbh with the FDA for Doro Radiolucent Headrest System And Horseshoe Headrests,and Non-radiolucent J-arm Retractor System (aluminum Alloy).

Pre-market Notification Details

• Device ID: K032331
• 510k Number: K032331
• Device Name: DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)
• Classification: Holder, Head, Neurosurgical (skull Clamp)
• Applicant: PRO-MED INSTRUMENTS GMBH 1899 SAWYER LANE Alva, FL 33920
• Contact: Jim Bazzinotti
• Correspondent: Jim Bazzinotti; PRO-MED INSTRUMENTS GMBH 1899 SAWYER LANE Alva, FL 33920
• Product Code: HBL
• CFR Regulation Number: 882.4460 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-07-29
• Decision Date: 2003-11-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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