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FDA 510(k)

BA-CPAS

K-Number: K945154 · 1995-01-13

ApplicantNobelpharma USA, Inc.
Decision Date1995-01-13
Product CodeFZE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BA-CPAS is the device name listed in this FDA 510(k) record. The listed applicant is Nobelpharma USA, Inc.. It received FDA 510(k) clearance on 1995-01-13 under 510(k) number K945154. The device is classified under product code FZE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BA-CPAS?

BA-CPAS is a medical device that received FDA 510(k) clearance on 1995-01-13. The listed applicant is Nobelpharma USA, Inc.. The 510(k) number is K945154.

When did BA-CPAS receive FDA 510(k) clearance?

BA-CPAS received FDA 510(k) clearance on 1995-01-13, under 510(k) number K945154.

Who is the listed applicant for BA-CPAS?

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

What is the FDA product code for BA-CPAS?

The FDA product code for BA-CPAS is FZE.

Other records listing Nobelpharma USA, 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.

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Related Devices (Code: FZE)

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.

K241253Medicon Epiplating SystemCmf Medicon Surgical, Inc.K161548Osseointegrated FixturesSouthern Implants (Pty), Ltd.K090803HANSON MEDICAL FACIAL IMPLANTSHanson Medical, Inc.K090630NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)Nobel Biocare ABK071018MONARCH NASAL IMPLANTHanson Medical, Inc.K041690MONARCH NASAL IMPLANTHanson Medical, 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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