The following data is part of a premarket notification filed by Leisegang Medical, Inc. with the FDA for Lm-100/200low Flow Insufflator.
| Device ID | K912789 |
| 510k Number | K912789 |
| Device Name: | LM-100/200LOW FLOW INSUFFLATOR |
| Classification | Insufflator, Hysteroscopic |
| Applicant | LEISEGANG MEDICAL, INC. 6401 CONGRESS AVE. Boca Raton, FL 33487 -2883 |
| Contact | Douglas Kwart |
| Correspondent | Douglas Kwart LEISEGANG MEDICAL, INC. 6401 CONGRESS AVE. Boca Raton, FL 33487 -2883 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-25 |
| Decision Date | 1991-09-20 |