LM 1000

Unit, Cryosurgical, Accessories

LEISEGANG MEDICAL, INC.

The following data is part of a premarket notification filed by Leisegang Medical, Inc. with the FDA for Lm 1000.

Pre-market Notification Details

• Device ID: K854767
• 510k Number: K854767
• Device Name: LM 1000
• Classification: Unit, Cryosurgical, Accessories
• Applicant: LEISEGANG MEDICAL, INC. 8801 S.W. 129 STREET Miami, FL 33176
• Contact: Douglas Kwart
• Correspondent: Douglas Kwart; LEISEGANG MEDICAL, INC. 8801 S.W. 129 STREET Miami, FL 33176
• Product Code: GEH
• CFR Regulation Number: 878.4350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-11-27
• Decision Date: 1986-01-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
60888937009974	K854767	000
00888937000122	K854767	000
00888937000139	K854767	000
00888937000146	K854767	000
00888937000153	K854767	000
00888937000160	K854767	000
00888937000177	K854767	000
00888937000184	K854767	000
00888937000191	K854767	000
00888937000207	K854767	000
00888937000214	K854767	000
00888937000221	K854767	000
00888937000238	K854767	000
00888937000245	K854767	000
00888937000252	K854767	000
60888937009967	K854767	000
00888937000108	K854767	000