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FDA 510(k)

BITE-BLOCK

K-Number: K833374 · 1983-11-03

ApplicantSontek Industries, Inc.
Decision Date1983-11-03
Product CodeJAY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BITE-BLOCK is the device name listed in this FDA 510(k) record. The listed applicant is Sontek Industries, Inc.. It received FDA 510(k) clearance on 1983-11-03 under 510(k) number K833374. The device is classified under product code JAY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BITE-BLOCK?

BITE-BLOCK is a medical device that received FDA 510(k) clearance on 1983-11-03. The listed applicant is Sontek Industries, Inc.. The 510(k) number is K833374.

When did BITE-BLOCK receive FDA 510(k) clearance?

BITE-BLOCK received FDA 510(k) clearance on 1983-11-03, under 510(k) number K833374.

Who is the listed applicant for BITE-BLOCK?

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

What is the FDA product code for BITE-BLOCK?

The FDA product code for BITE-BLOCK is JAY.

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Other records listing Sontek Industries, 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.

K833373BODIA BRONCH-SAF DOUBLE SWIVELK833372BODIA TRACH-SAF DOUBLE SWIVELK833361TUBE-TITLEK813324BODAI SWIVEL YK812720BODAI PATIENT COMMUNICATORK811241BODAI SUCTION -SAFE 4

View all 7 devices →

Related Devices (Code: JAY)

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.

K944988CUSTOM MEDICAL SUSPENSION STRAPCustom Medical Specialties, Inc.K873491BLOCK, BITE, INTUBATIONB&B Medical Technologies, Inc.K860583DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315Dale Medical Products, Inc.K850924JEE FRAME (VENTILATOR CIRCUIT SUPPORT)Vulcan Laboratories, Inc.K850309COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCKAckrad LaboratoriesK840844ENDO-SECUREExidyne, 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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