Atlas FDA

UNICET I

FDA 510(k) clearance K770529 · decided 1977-04-05

Clearance details

K-number
K770529
Device name
UNICET I
Applicant
Union Carbide Corp.
Decision
Substantially Equivalent
Date received
1977-03-21
Decision date
1977-04-05
Days to decision
15 days
Clearance type
Traditional
Product code
IPS
Device class
1
Regulation number
890.3075
Medical specialty
Physical Medicine
Advisory committee
Physical Medicine
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Union Carbide Corp.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
CANE REACHER (K832970)Maddak, Inc.1983-09-29
WALKING CANE (K832969)Maddak, Inc.1983-09-29
LIGHT WEIGHT ALUMINUM CANES (K821402)Manuco Manufacturing Co., Inc.1982-04-21
CERSA-CANE (K790558)Maddak, Inc.1979-04-03
OFFSET ALUMINUM CANE (K790561)Maddak, Inc.1979-04-03
FOREARM-CANE (K790299)Guardian Products Co., Inc.1979-02-21
CANE/REACHER (K780085)Fred Sammons, Inc.1978-01-30
QUADRAPLEGIC WALKING AID (K772267)Med Fusion Systems, Inc.1977-12-20

Recalls involving this device

No recalls on record reference this clearance.