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FDA 510(k)

LUBRICATING JELLY, LOW VISCOSITY

K-Number: K961502 · 1996-07-18

ApplicantSpan-America Medical Systems, Inc.
Decision Date1996-07-18
Product CodeKMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LUBRICATING JELLY, LOW VISCOSITY 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 1996-07-18 under 510(k) number K961502. 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 LUBRICATING JELLY, LOW VISCOSITY?

LUBRICATING JELLY, LOW VISCOSITY is a medical device that received FDA 510(k) clearance on 1996-07-18. The listed applicant is Span-America Medical Systems, Inc.. The 510(k) number is K961502.

When did LUBRICATING JELLY, LOW VISCOSITY receive FDA 510(k) clearance?

LUBRICATING JELLY, LOW VISCOSITY received FDA 510(k) clearance on 1996-07-18, under 510(k) number K961502.

Who is the listed applicant for LUBRICATING JELLY, LOW VISCOSITY?

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 LUBRICATING JELLY, LOW VISCOSITY?

The FDA product code for LUBRICATING JELLY, LOW VISCOSITY 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: SELECTCAREK961159POWERED LOW AIR LOSS MATTRESS SYSTEMK960620PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEMK960189GEL-T CUSHION

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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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