DEKALB

Laparoscope, General & Plastic Surgery

ENDOTEC, INC.

The following data is part of a premarket notification filed by Endotec, Inc. with the FDA for Dekalb.

Pre-market Notification Details

• Device ID: K944414
• 510k Number: K944414
• Device Name: DEKALB
• Classification: Laparoscope, General & Plastic Surgery
• Applicant: ENDOTEC, INC. 6550A BEST FRIEND RD. Norcross, GA 30071
• Contact: Freddie P Andrieni
• Correspondent: Freddie P Andrieni; ENDOTEC, INC. 6550A BEST FRIEND RD. Norcross, GA 30071
• Product Code: GCJ
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-09-08
• Decision Date: 1994-09-27