510(k) K905392
K905392 is an FDA 510(k) premarket notification submitted by Frigitronics, Inc. for the device "HT4-SERIES HYSTEROSCOPES AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on April 30, 1991. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Frigitronics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 1991
- Date Received
- November 30, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hysteroscope (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1690
- Review Panel
- OB
- Submission Type