510(k) K770349

RIGID TEACHING ATTACHMENT by Richard Wolf Medical Instruments Corp. — Product Code HWN

K770349 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corp. for the device "RIGID TEACHING ATTACHMENT". The FDA issued a decision of Substantially Equivalent on March 7, 1977. The device falls under product code HWN (Instrument, Compression), a Class I device regulated under 21 CFR 888.4540. Richard Wolf Medical Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1977
Date Received
February 22, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Compression
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type