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FDA 510(k)

MEDI GUARD PILLOWCASE

K-Number: K911948 · 1991-05-28

ApplicantSancella, Inc.
Decision Date1991-05-28
Product CodeKME
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDI GUARD PILLOWCASE is the device name listed in this FDA 510(k) record. The listed applicant is Sancella, Inc.. It received FDA 510(k) clearance on 1991-05-28 under 510(k) number K911948. The device is classified under product code KME. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDI GUARD PILLOWCASE?

MEDI GUARD PILLOWCASE is a medical device that received FDA 510(k) clearance on 1991-05-28. The listed applicant is Sancella, Inc.. The 510(k) number is K911948.

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

MEDI GUARD PILLOWCASE received FDA 510(k) clearance on 1991-05-28, under 510(k) number K911948.

Who is the listed applicant for MEDI GUARD PILLOWCASE?

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 PILLOWCASE?

The FDA product code for MEDI GUARD PILLOWCASE is KME.

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.

K911944MEDI GUARD DENTAL BIBK911952MEDI GUARD UNDERPADK911953MEDI GUARD SHEETS/UNDERLAYSK911950MEDI GUARD DRAPES

Related Devices (Code: KME)

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.

K042145READY-HEAT BLANKETTechtrade, LLCK944953OREX MEDICAL BEDDINGThantex Specialties, Inc.K933636DISPOSE-A-SHEETBelmac Healthcare Corp.K932539DOCTOR DOWN --RESCUE WRAPThree Dog DownK922143AMERICAN BURN SHEETAmerican Silk Sutures, Inc.K915303FOIL BABY BUNTINGGam Industries, Inc.

Official Source

View on FDA Database →

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

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