510(k) K863275

MARTIN MEDICAL PRO-SPEC SMALL VAGINAL SPECULUM by Martin Medical — Product Code HIB

K863275 is an FDA 510(k) premarket notification submitted by Martin Medical for the device "MARTIN MEDICAL PRO-SPEC SMALL VAGINAL SPECULUM". The FDA issued a decision of Substantially Equivalent on September 2, 1986. The device falls under product code HIB (Speculum, Vaginal, Nonmetal), a Class II device regulated under 21 CFR 884.4530. Martin Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1986
Date Received
August 25, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Speculum, Vaginal, Nonmetal
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type