510(k) K872905

AMERICAN NASAL SPONGE by American Silk Sutures, Inc. — Product Code EPP

K872905 is an FDA 510(k) premarket notification submitted by American Silk Sutures, Inc. for the device "AMERICAN NASAL SPONGE". The FDA issued a decision of Substantially Equivalent on September 4, 1987. The device falls under product code EPP (Splint, Nasal), a Class I device regulated under 21 CFR 874.5800. American Silk Sutures, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1987
Date Received
July 24, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Nasal
Device Class
Class I
Regulation Number
874.5800
Review Panel
EN
Submission Type