510(k) K893869

GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE) by Adept-Med Intl., Inc. — Product Code GAD

K893869 is an FDA 510(k) premarket notification submitted by Adept-Med Intl., Inc. for the device "GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE)". The FDA issued a decision of Substantially Equivalent on August 3, 1989. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Adept-Med Intl., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1989
Date Received
May 26, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type