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FDA 510(k)

STERILE SPONGE BOWLS

K-Number: K800440 · 1980-04-29

ApplicantPremium Plastics, Inc.
Decision Date1980-04-29
Product CodeFNY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILE SPONGE BOWLS is the device name listed in this FDA 510(k) record. The listed applicant is Premium Plastics, Inc.. It received FDA 510(k) clearance on 1980-04-29 under 510(k) number K800440. The device is classified under product code FNY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE SPONGE BOWLS?

STERILE SPONGE BOWLS is a medical device that received FDA 510(k) clearance on 1980-04-29. The listed applicant is Premium Plastics, Inc.. The 510(k) number is K800440.

When did STERILE SPONGE BOWLS receive FDA 510(k) clearance?

STERILE SPONGE BOWLS received FDA 510(k) clearance on 1980-04-29, under 510(k) number K800440.

Who is the listed applicant for STERILE SPONGE BOWLS?

The FDA 510(k) record lists Premium Plastics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE SPONGE BOWLS?

The FDA product code for STERILE SPONGE BOWLS is FNY.

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Other records listing Premium Plastics, 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.

K953226PULM O2 SUCTION CATHETER TRAYSK950851GENT-L-KARE TRACHEOSTOMY TRAYSK950850GENT-L-KARE LACERATION TRAYSK943740ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)K890107GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KITK893135GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER

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Related Devices (Code: FNY)

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.

K832826AAP DOSIMETRY RELEASE OR BASIN SETSAmerican Hospital Supply Corp.K802538BASIN PACKTexas Medical Products, Inc.K792625STERILIZATION PROCESS/PLACENTA BASINProcter & Gamble Mfg. Co.K7717338 EMESIS BASINBemis Health CareK760494BASIN, ROUND WASHLandmark PlasticsK760495BASIN, RECTANGULAR WASHLandmark Plastics

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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