510(k) K831367

PMN VOLZ CURETTES by 3M Company — Product Code FZS

K831367 is an FDA 510(k) premarket notification submitted by 3M Company for the device "PMN VOLZ CURETTES". The FDA issued a decision of Substantially Equivalent on May 25, 1983. The device falls under product code FZS (Curette, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800. 3M Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1983
Date Received
April 26, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Curette, Surgical, General Use
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type