LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660

Ligator, Hemorrhoidal

SAPI MED S.P.A

The following data is part of a premarket notification filed by Sapi Med S.p.a with the FDA for Lem Hemorrhoidal Ligator, Models A.5650, A.5660.

Pre-market Notification Details

• Device ID: K070881
• 510k Number: K070881
• Device Name: LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
• Classification: Ligator, Hemorrhoidal
• Applicant: SAPI MED S.P.A 1676 VILLAGE GREEN SUITE A Crofton, MD 21114
• Contact: E.j. Smith
• Correspondent: E.j. Smith; SAPI MED S.P.A 1676 VILLAGE GREEN SUITE A Crofton, MD 21114
• Product Code: FHN
• CFR Regulation Number: 876.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-03-30
• Decision Date: 2007-09-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08033638803318	K070881	000
08033638802335	K070881	000
08033638801680	K070881	000