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FDA 510(k)

CATCO NEONATAL PALATE GUARD

K-Number: K945727 · 1994-12-07

ApplicantCatco Medical, Inc.
Decision Date1994-12-07
Product CodeBRW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CATCO NEONATAL PALATE GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Catco Medical, Inc.. It received FDA 510(k) clearance on 1994-12-07 under 510(k) number K945727. The device is classified under product code BRW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATCO NEONATAL PALATE GUARD?

CATCO NEONATAL PALATE GUARD is a medical device that received FDA 510(k) clearance on 1994-12-07. The listed applicant is Catco Medical, Inc.. The 510(k) number is K945727.

When did CATCO NEONATAL PALATE GUARD receive FDA 510(k) clearance?

CATCO NEONATAL PALATE GUARD received FDA 510(k) clearance on 1994-12-07, under 510(k) number K945727.

Who is the listed applicant for CATCO NEONATAL PALATE GUARD?

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

What is the FDA product code for CATCO NEONATAL PALATE GUARD?

The FDA product code for CATCO NEONATAL PALATE GUARD is BRW.

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Other records listing Catco 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.

K945728CATCO THORACIC CATHETERK944336CATCO UMBILICAL VESSEL CATHETERK944367CATCO POLYURETHANE UMBILICAL VESSEL CATHETERK944368CATCO SILICONE UMBILICAL VESSEL CATHETERK944410CATCO SILICONE DUAL LUMEN UMBILICAL VESSEL CATHETERK944504CATCO FIRST PICC

View all 12 devices →

Related Devices (Code: BRW)

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.

K935713WILEY/ESPOSITO DENTAL GUARDFvtnksK851640TIP TOLEDO INCISOR PROTECTOREdward O. Goodwich

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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