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FDA 510(k)

GRAM-MA NEONATAL SC

K-Number: K853475 · 1985-09-05

ApplicantKentec Medical, Inc.
Decision Date1985-09-05
Product CodeFRW
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GRAM-MA NEONATAL SC is the device name listed in this FDA 510(k) record. The listed applicant is Kentec Medical, Inc.. It received FDA 510(k) clearance on 1985-09-05 under 510(k) number K853475. The device is classified under product code FRW. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAM-MA NEONATAL SC?

GRAM-MA NEONATAL SC is a medical device that received FDA 510(k) clearance on 1985-09-05. The listed applicant is Kentec Medical, Inc.. The 510(k) number is K853475.

When did GRAM-MA NEONATAL SC receive FDA 510(k) clearance?

GRAM-MA NEONATAL SC received FDA 510(k) clearance on 1985-09-05, under 510(k) number K853475.

Who is the listed applicant for GRAM-MA NEONATAL SC?

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

What is the FDA product code for GRAM-MA NEONATAL SC?

The FDA product code for GRAM-MA NEONATAL SC is FRW.

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Other records listing Kentec Medical, 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.

K120272AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SETK100526AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBEK050443ACCU-LEADK970686ACCUTEMP-PROBEK960080ACCUTEMP PROBE

Related Devices (Code: FRW)

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.

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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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