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FDA 510(k)

AUTOCLAVE POUCHES&ROLLS/STEAM&GAS

K-Number: K780034 · 1978-02-21

ApplicantE.M. Adams
Decision Date1978-02-21
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AUTOCLAVE POUCHES&ROLLS/STEAM&GAS is the device name listed in this FDA 510(k) record. The listed applicant is E.M. Adams. It received FDA 510(k) clearance on 1978-02-21 under 510(k) number K780034. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOCLAVE POUCHES&ROLLS/STEAM&GAS?

AUTOCLAVE POUCHES&ROLLS/STEAM&GAS is a medical device that received FDA 510(k) clearance on 1978-02-21. The listed applicant is E.M. Adams. The 510(k) number is K780034.

When did AUTOCLAVE POUCHES&ROLLS/STEAM&GAS receive FDA 510(k) clearance?

AUTOCLAVE POUCHES&ROLLS/STEAM&GAS received FDA 510(k) clearance on 1978-02-21, under 510(k) number K780034.

Who is the listed applicant for AUTOCLAVE POUCHES&ROLLS/STEAM&GAS?

The FDA 510(k) record lists E.M. Adams as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOCLAVE POUCHES&ROLLS/STEAM&GAS?

The FDA product code for AUTOCLAVE POUCHES&ROLLS/STEAM&GAS is FRG.

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Other records listing E.M. Adams 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.

K905173SPLASH GUARDK910468STERILE DISPOSABLE DRAPE(S)K873978DISPOSABLE BIPOLAR FORCEPSK850063INSTRUMENT POCKETK843724I.V. START KIT & OBSTETRICAL KITK843783WET PACK

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Related Devices (Code: FRG)

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.

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing 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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