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FDA 510(k)

PDI SURGICAL SCRUB SPONGE-BRUSH-T15070

K-Number: K810337 · 1981-02-26

ApplicantNice-Pak Products, Inc.
Decision Date1981-02-26
Product CodeGEC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PDI SURGICAL SCRUB SPONGE-BRUSH-T15070 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 1981-02-26 under 510(k) number K810337. The device is classified under product code GEC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PDI SURGICAL SCRUB SPONGE-BRUSH-T15070?

PDI SURGICAL SCRUB SPONGE-BRUSH-T15070 is a medical device that received FDA 510(k) clearance on 1981-02-26. The listed applicant is Nice-Pak Products, Inc.. The 510(k) number is K810337.

When did PDI SURGICAL SCRUB SPONGE-BRUSH-T15070 receive FDA 510(k) clearance?

PDI SURGICAL SCRUB SPONGE-BRUSH-T15070 received FDA 510(k) clearance on 1981-02-26, under 510(k) number K810337.

Who is the listed applicant for PDI SURGICAL SCRUB SPONGE-BRUSH-T15070?

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 SURGICAL SCRUB SPONGE-BRUSH-T15070?

The FDA product code for PDI SURGICAL SCRUB SPONGE-BRUSH-T15070 is GEC.

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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.

K974768PDI STERILE LUBRICATING JELLYK840343PDI PREPMASTER WET PACK VAGINAL-X21477K840342PDI PREPMASTER WET PACK PATIENT PREP KITK840344PDI PREPMASTER WET PACK MINOR PROCEDUREK833549PDI SURGICAL SCRUB/BRUSH T150-70K781539ISO-CARE KIT

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Related Devices (Code: GEC)

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.

K971473IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCKM-Pact Worldwide Management Corp.K960621EXPANDACELL INSTRUMENT WIPEShippert Medical Technologies Corp.K900691BIODYNE INSTRUMENT WIPESBio-Dyne, Inc.K896085SURGI-BRUSHSparta Surgical Corp.K875033STERILE SCRUBBY SCRUB BRUSHMedsurg Industries, Inc.K875129STERI-CLENSAbsorbent Cotton Co., 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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