510(k) K912789
K912789 is an FDA 510(k) premarket notification submitted by Leisegang Medical, Inc. for the device "LM-100/200LOW FLOW INSUFFLATOR". The FDA issued a decision of Substantially Equivalent on September 20, 1991. The device falls under product code HIG (Insufflator, Hysteroscopic), a Class II device regulated under 21 CFR 884.1700. Leisegang Medical, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 1991
- Date Received
- June 25, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insufflator, Hysteroscopic
- Device Class
- Class II
- Regulation Number
- 884.1700
- Review Panel
- OB
- Submission Type