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FDA 510(k)

MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0

K-Number: K882506 · 1988-09-09

ApplicantSpan-America Medical Systems, Inc.
Decision Date1988-09-09
Product CodeKMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0 is the device name listed in this FDA 510(k) record. The listed applicant is Span-America Medical Systems, Inc.. It received FDA 510(k) clearance on 1988-09-09 under 510(k) number K882506. The device is classified under product code KMJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0?

MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0 is a medical device that received FDA 510(k) clearance on 1988-09-09. The listed applicant is Span-America Medical Systems, Inc.. The 510(k) number is K882506.

When did MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0 receive FDA 510(k) clearance?

MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0 received FDA 510(k) clearance on 1988-09-09, under 510(k) number K882506.

Who is the listed applicant for MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0?

The FDA 510(k) record lists Span-America Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0?

The FDA product code for MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0 is KMJ.

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Other records listing Span-America Medical Systems, 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.

K973169PRESSURE GUARD SITE SELECT (A)K972486PRESSUREGUARD IVK960188PRESSUREGUARD: SELECTCAREK961502LUBRICATING JELLY, LOW VISCOSITYK961159POWERED LOW AIR LOSS MATTRESS SYSTEMK960620PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM

View all 19 devices →

Related Devices (Code: KMJ)

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.

K131617COLONGLIDE(R) LUBRICANTPediatric Pharmaceuticals, Inc.K121390LUBE JELLY SURINGENurse Assist, Inc.K113689DUKAL LUBRICATING JELLYDukal CorporationK112110STERILE LUBRICATING JELLYJianerkang Medical Dressing CompanyK103718DYNACOR LUBRICATION GELMedline Industries, Inc.K101522ULTRA SEAL STERILE LUBRICATING JELLYUltra Seal Corporation

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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