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FDA 510(k)

PDI STERILE LUBRICATING JELLY

K-Number: K974768 · 1998-01-16

ApplicantNice-Pak Products, Inc.
Decision Date1998-01-16
Product CodeKMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PDI STERILE LUBRICATING JELLY is the device name listed in this FDA 510(k) record. The listed applicant is Nice-Pak Products, Inc.. It received FDA 510(k) clearance on 1998-01-16 under 510(k) number K974768. 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 PDI STERILE LUBRICATING JELLY?

PDI STERILE LUBRICATING JELLY is a medical device that received FDA 510(k) clearance on 1998-01-16. The listed applicant is Nice-Pak Products, Inc.. The 510(k) number is K974768.

When did PDI STERILE LUBRICATING JELLY receive FDA 510(k) clearance?

PDI STERILE LUBRICATING JELLY received FDA 510(k) clearance on 1998-01-16, under 510(k) number K974768.

Who is the listed applicant for PDI STERILE LUBRICATING JELLY?

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

What is the FDA product code for PDI STERILE LUBRICATING JELLY?

The FDA product code for PDI STERILE LUBRICATING JELLY is KMJ.

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Other records listing Nice-Pak Products, 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.

K840343PDI PREPMASTER WET PACK VAGINAL-X21477K840342PDI PREPMASTER WET PACK PATIENT PREP KITK840344PDI PREPMASTER WET PACK MINOR PROCEDUREK833549PDI SURGICAL SCRUB/BRUSH T150-70K810337PDI SURGICAL SCRUB SPONGE-BRUSH-T15070K781539ISO-CARE KIT

View all 9 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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