510(k) K882244

RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT by Richards Medical Co., Inc. — Product Code EPP

K882244 is an FDA 510(k) premarket notification submitted by Richards Medical Co., Inc. for the device "RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT". The FDA issued a decision of Substantially Equivalent on June 23, 1988. The device falls under product code EPP (Splint, Nasal), a Class I device regulated under 21 CFR 874.5800. Richards Medical Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1988
Date Received
May 31, 1988
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