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510(k) K933537

Device
ENCOMPAS COMFORT BLOCK # 0B-10
Applicant
Encompas Unlimited, Inc.
510(k) number
K933537
Product code
MNK
Decision
Substantially Equivalent (SESE)
Decision date
1994-04-08
Date received
1993-07-21
Regulation
876.1500
Classification name
Endoscopic Bite Block
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL P CAPPELLI
Address
1110 Pinellas Bayway Suite 104 Tierra Verde FL US 33715 33715

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MNK#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K944049OXYGEN MOUTHGUARDEndovations, Inc.1994-10-11
K931044OXY-BLOCGi Supply1993-10-04
K924764OVERTUBE FOR ENDSCOPIC LIGATORSuperior Healthcare Group, Inc.1993-03-15
K914978OXYGUARDStantex Pty , Ltd.1992-01-10
K896691BITE BLOCKEndoscopix1990-02-12