510(k) K801351

EPILATOR, MODEL CP-16 by R. A. Fischer Co. Corp. — Product Code KCW

K801351 is an FDA 510(k) premarket notification submitted by R. A. Fischer Co. Corp. for the device "EPILATOR, MODEL CP-16". The FDA issued a decision of Substantially Equivalent on Jul 28, 1980. The device falls under product code KCW (Epilator, High Frequency, Needle-Type), a Class I device regulated under 21 CFR 878.5350. R. A. Fischer Co. Corp. has 12 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 28, 1980
Date Received
Jun 9, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Epilator, High Frequency, Needle-Type
Device Class
Class I
Regulation Number
878.5350
Review Panel
SU
Submission Type
510(k) Exempt

Source: FDA 510(k) database entry for K801351. Report a data issue: hello@regdatalab.com.