APOLLO

Electrosurgical, Cutting & Coagulation & Accessories

POLLOGEN LTD

The following data is part of a premarket notification filed by Pollogen Ltd with the FDA for Apollo.

Pre-market Notification Details

• Device ID: K111026
• 510k Number: K111026
• Device Name: APOLLO
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: POLLOGEN LTD 31 HAAVODA ST. Binyamina, IL 30500
• Contact: Yoram Levy
• Correspondent: Yoram Levy; POLLOGEN LTD 31 HAAVODA ST. Binyamina, IL 30500
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-04-13
• Decision Date: 2011-11-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07290016586039	K111026	000
07290016586022	K111026	000
07290016586015	K111026	000