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FDA 510(k)

NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH.

K-Number: K896321 · 1989-11-13

ApplicantSuperior Healthcare Group, Inc.
Decision Date1989-11-13
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH. is the device name listed in this FDA 510(k) record. The listed applicant is Superior Healthcare Group, Inc.. It received FDA 510(k) clearance on 1989-11-13 under 510(k) number K896321. The device is classified under product code BSY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH.?

NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH. is a medical device that received FDA 510(k) clearance on 1989-11-13. The listed applicant is Superior Healthcare Group, Inc.. The 510(k) number is K896321.

When did NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH. receive FDA 510(k) clearance?

NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH. received FDA 510(k) clearance on 1989-11-13, under 510(k) number K896321.

Who is the listed applicant for NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH.?

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

What is the FDA product code for NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH.?

The FDA product code for NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH. is BSY.

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Other records listing Superior Healthcare Group, 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.

K925530INSTRUMENT WARMERK924764OVERTUBE FOR ENDSCOPIC LIGATORK905755NON-STERILE PATIENT EXAMINATION GLOVESK903347SODIUM CHLORIDE SOLUTIONK904216STERILE WATER SOLUTION CATALOG # 10000K903340STERILE URETHRAL CATHETER PROCEDURE KITS

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Related Devices (Code: BSY)

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.

K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMMallinckrodt Dar S.R.L.K992902AMBU HAND POWER SUCTION PUMPAmbu, Inc.K982945DUAL PURPOSE CLOSED CATHETERSpirit Medical Systems, Inc.K981910SUCTION CATHETERNi-Med, Inc.K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt MedicalK973199AMSINO SUCTION CATHETERAmsino Intl., 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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