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FDA 510(k)

ENCOMPAS COMFORT BLOCK # 0B-10

K-Number: K933537 · 1994-04-08

ApplicantEncompas Unlimited, Inc.
Decision Date1994-04-08
Product CodeMNK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENCOMPAS COMFORT BLOCK # 0B-10 is the device name listed in this FDA 510(k) record. The listed applicant is Encompas Unlimited, Inc.. It received FDA 510(k) clearance on 1994-04-08 under 510(k) number K933537. The device is classified under product code MNK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENCOMPAS COMFORT BLOCK # 0B-10?

ENCOMPAS COMFORT BLOCK # 0B-10 is a medical device that received FDA 510(k) clearance on 1994-04-08. The listed applicant is Encompas Unlimited, Inc.. The 510(k) number is K933537.

When did ENCOMPAS COMFORT BLOCK # 0B-10 receive FDA 510(k) clearance?

ENCOMPAS COMFORT BLOCK # 0B-10 received FDA 510(k) clearance on 1994-04-08, under 510(k) number K933537.

Who is the listed applicant for ENCOMPAS COMFORT BLOCK # 0B-10?

The FDA 510(k) record lists Encompas Unlimited, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENCOMPAS COMFORT BLOCK # 0B-10?

The FDA product code for ENCOMPAS COMFORT BLOCK # 0B-10 is MNK.

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Related Devices (Code: MNK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K944049OXYGEN MOUTHGUARDEndovations, Inc.K931044OXY-BLOCGi SupplyK924764OVERTUBE FOR ENDSCOPIC LIGATORSuperior Healthcare Group, Inc.K914978OXYGUARDStantex Pty , Ltd.K896691BITE BLOCKEndoscopix

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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