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FDA 510(k)

MEDI GUARD DENTAL BIB

K-Number: K911944 · 1991-10-04

ApplicantSancella, Inc.
Decision Date1991-10-04
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDI GUARD DENTAL BIB is the device name listed in this FDA 510(k) record. The listed applicant is Sancella, Inc.. It received FDA 510(k) clearance on 1991-10-04 under 510(k) number K911944. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDI GUARD DENTAL BIB?

MEDI GUARD DENTAL BIB is a medical device that received FDA 510(k) clearance on 1991-10-04. The listed applicant is Sancella, Inc.. The 510(k) number is K911944.

When did MEDI GUARD DENTAL BIB receive FDA 510(k) clearance?

MEDI GUARD DENTAL BIB received FDA 510(k) clearance on 1991-10-04, under 510(k) number K911944.

Who is the listed applicant for MEDI GUARD DENTAL BIB?

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

What is the FDA product code for MEDI GUARD DENTAL BIB?

The FDA product code for MEDI GUARD DENTAL BIB is KKX.

Related Clinical Trials

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Other records listing Sancella, Inc. as applicant

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.

K911952MEDI GUARD UNDERPADK911953MEDI GUARD SHEETS/UNDERLAYSK911948MEDI GUARD PILLOWCASEK911950MEDI GUARD DRAPES

Related Devices (Code: KKX)

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.

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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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