510(k) K870184
K870184 is an FDA 510(k) premarket notification submitted by Fraass Survival Systems, Inc. for the device "BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES". The FDA issued a decision of Substantially Equivalent on February 6, 1987. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Fraass Survival Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 6, 1987
- Date Received
- January 16, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type