510(k) K800669

FELDMAN MINI-SAW, #300000 by KARL STORZ Endoscopy-America, Inc. — Product Code EWQ

K800669 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "FELDMAN MINI-SAW, #300000". The FDA issued a decision of Substantially Equivalent on April 21, 1980. The device falls under product code EWQ (Saw, Surgical, Ent (Electric Or Pneumatic)), a Class I device regulated under 21 CFR 874.4420. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1980
Date Received
March 26, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saw, Surgical, Ent (Electric Or Pneumatic)
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type