510(k) K812895

YARMO NASAL CARTILAGE SOFTENER by American V. Mueller — Product Code KAE

K812895 is an FDA 510(k) premarket notification submitted by American V. Mueller for the device "YARMO NASAL CARTILAGE SOFTENER". The FDA issued a decision of Substantially Equivalent on Nov 2, 1981. The device falls under product code KAE (Forceps, Ent), a Class I device regulated under 21 CFR 874.4420. American V. Mueller has 30 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 2, 1981
Date Received
Oct 15, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Forceps, Ent
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type
510(k) Exempt

Source: FDA 510(k) database entry for K812895. Report a data issue: hello@regdatalab.com.