510(k) K901348
K901348 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "WILSON-COOK BRONCHOSCOPE BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on October 9, 1990. The device falls under product code EGQ (Injector, Jet, Gas-Powered), a Class II device regulated under 21 CFR 872.4465. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 1990
- Date Received
- March 23, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injector, Jet, Gas-Powered
- Device Class
- Class II
- Regulation Number
- 872.4465
- Review Panel
- DE
- Submission Type