Atlas FDA

TENZCARE STIMULATOR 6890

FDA 510(k) clearance K891992 · decided 1989-10-12

Clearance details

K-number
K891992
Device name
TENZCARE STIMULATOR 6890
Applicant
3M Company
Decision
Substantially Equivalent
Date received
1989-03-28
Decision date
1989-10-12
Days to decision
198 days
Clearance type
Traditional
Product code
GZJ
Device class
2
Regulation number
882.5890
Medical specialty
Neurology
Advisory committee
Neurology
Location
Cottae Grove, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011)3M Company1994-11-28
CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010)3M Company1994-05-19
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006)3M Company1992-12-31
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009)3M Company1992-03-13
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008)3M Company1992-01-28
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007)3M Company1990-10-17
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005)3M Company1990-03-08
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004)3M Company1989-11-22