510(k) K893949
K893949 is an FDA 510(k) premarket notification submitted by Medmark, Inc. for the device "#157 EXAM LIGHT". The FDA issued a decision of Substantially Equivalent on August 7, 1989. The device falls under product code KFK (Saw, Pneumatically Powered), a Class I device regulated under 21 CFR 878.4820. Medmark, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 1989
- Date Received
- June 1, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Saw, Pneumatically Powered
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type