Burton H- Base Table - Model 1990

FDA 510(k) K924773 · R.H. Burton Co.

Substantially Equivalent

510(k) numberK924773

Submission

Device name
Burton H- Base Table - Model 1990
Applicant
R.H. Burton Co.
Grove City, OH, US
Received
September 23, 1992
Decision date
June 7, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HRX – Arthroscope
Device class
Class II (moderate risk)
Regulation
21 CFR 888.1100
Specialty
Orthopedic

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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More from Hand Biomechanics Lab, Inc.

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K924784Burton Projector Head - Model 6000-HHOS · Traditional 04/05/1993SE
K924780Burton Ophthalmic Exam Unit - Model 2201HMF · Traditional 04/05/1993SE
K924779Burton Keratometer - Modle 2040HJB · Traditional 04/05/1993SE
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Questions and answers

When was Burton H- Base Table - Model 1990 cleared by the FDA?

Burton H- Base Table - Model 1990 (K924773) received a 510(k) decision of Substantially Equivalent on June 7, 1993, 257 days after the submission was received.

What is the product code of K924773?

The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.