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FDA 510(k)

1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT

K-Number: K895202 · 1989-09-15

ApplicantTransidyne General Corp.
Decision Date1989-09-15
Product CodeLRO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Transidyne General Corp.. It received FDA 510(k) clearance on 1989-09-15 under 510(k) number K895202. The device is classified under product code LRO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT?

1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT is a medical device that received FDA 510(k) clearance on 1989-09-15. The listed applicant is Transidyne General Corp.. The 510(k) number is K895202.

When did 1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT receive FDA 510(k) clearance?

1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT received FDA 510(k) clearance on 1989-09-15, under 510(k) number K895202.

Who is the listed applicant for 1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT?

The FDA 510(k) record lists Transidyne General Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT?

The FDA product code for 1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT is LRO.

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Other records listing Transidyne General Corp. as applicant

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K961217BODILY FLUID DISPOSAL KITK955658LACERATION TRAYK950773PROPHYLAXIS PACKK950743ORAL PROCEDURE PACKK950449SURGICAL BURK950403SURGICAL SAW BLADES

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Related Devices (Code: LRO)

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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