510(k) K940903
K940903 is an FDA 510(k) premarket notification submitted by Medical Insights, Inc. for the device "TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES". The FDA issued a decision of Substantially Equivalent on April 14, 1994. The device falls under product code KBM (Dissector, Tonsil), a Class I device regulated under 21 CFR 874.4420. Medical Insights, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 1994
- Date Received
- February 24, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dissector, Tonsil
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type