510(k) K874410
K874410 is an FDA 510(k) premarket notification submitted by Cumes-Honikman Partnership for the device "CUMEVAC". The FDA issued a decision of Substantially Equivalent on December 3, 1987. The device falls under product code FFD (Evacuator, Bladder, Manually Operated), a Class I device regulated under 21 CFR 876.4370.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 1987
- Date Received
- October 28, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Evacuator, Bladder, Manually Operated
- Device Class
- Class I
- Regulation Number
- 876.4370
- Review Panel
- GU
- Submission Type