510(k) K827577
K827577 is an FDA 510(k) premarket notification submitted by Randwal Instrument Co., Inc. for the device "VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETER". The FDA issued a decision of Substantially Equivalent on January 24, 1983. Randwal Instrument Co., Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 24, 1983
- Date Received
- December 20, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No