510(k) K801853
K801853 is an FDA 510(k) premarket notification submitted by C.D. Charles, Inc. for the device "PARALLEL-A-PREP". The FDA issued a decision of Substantially Equivalent on August 13, 1980. The device falls under product code EGI (Parallelometer), a Class I device regulated under 21 CFR 872.4565.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 1980
- Date Received
- August 4, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Parallelometer
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type