510(k) K903718
K903718 is an FDA 510(k) premarket notification submitted by Cygnus Instruments, Inc. for the device "OROSCOPE MODEL NUMBER COS-100". The FDA issued a decision of Substantially Equivalent on November 9, 1990. The device falls under product code EHZ (Evacuator, Oral Cavity), a Class I device regulated under 21 CFR 872.6640. Cygnus Instruments, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 1990
- Date Received
- August 16, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Evacuator, Oral Cavity
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type