Atlas FDA

ADJUSTABLE FORK RETRACTOR

FDA 510(k) clearance K833604 · decided 1984-01-03

Clearance details

K-number
K833604
Device name
ADJUSTABLE FORK RETRACTOR
Applicant
Microtek Medical, Inc.
Decision
Substantially Equivalent
Date received
1983-10-12
Decision date
1984-01-03
Days to decision
83 days
Clearance type
Traditional
Product code
KAL
Device class
1
Regulation number
874.4420
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
SMALL MASTOID RETRACTOR (K870758)Treace Medical, Inc.1987-03-04
RING HANDLE & RETRACTORS (K772381)Edward Weck, Inc.1978-01-17
ALLPORT MASTOID RETRACTORS (K772392)Edward Weck, Inc.1978-01-17
CONVERSE ALTAR RETRACTOR (K760851)V. Mueller O.V. Baxter Healthcare Corp.1977-03-10

Recalls involving this device

No recalls on record reference this clearance.