510(k) K870240
K870240 is an FDA 510(k) premarket notification submitted by Fraass Survival Systems, Inc. for the device "COMPRESS AND SKULLCAP, HEAD DRESSING". The FDA issued a decision of Substantially Equivalent on February 20, 1987. The device falls under product code EXR (Urinometer, Mechanical), a Class II device regulated under 21 CFR 876.1800. Fraass Survival Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 20, 1987
- Date Received
- January 21, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Urinometer, Mechanical
- Device Class
- Class II
- Regulation Number
- 876.1800
- Review Panel
- GU
- Submission Type