510(k) K874766

INTERPRO INT'L, INC. ISOLATION GOWN by Interpro Intl., Inc. — Product Code FYC

K874766 is an FDA 510(k) premarket notification submitted by Interpro Intl., Inc. for the device "INTERPRO INT'L, INC. ISOLATION GOWN". The FDA issued a decision of Substantially Equivalent on December 10, 1987. The device falls under product code FYC (Gown, Isolation, Surgical), a Class II device regulated under 21 CFR 878.4040. Interpro Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1987
Date Received
November 19, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Isolation, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type