Atlas FDA

3M DIGITAL DISK INTERFACE UNIT

FDA 510(k) clearance K920268 · decided 1992-05-27

Clearance details

K-number
K920268
Device name
3M DIGITAL DISK INTERFACE UNIT
Applicant
3M Company
Decision
Substantially Equivalent
Date received
1992-01-21
Decision date
1992-05-27
Days to decision
127 days
Clearance type
Traditional
Product code
LMD
Device class
1
Regulation number
892.2020
Medical specialty
Radiology
Advisory committee
Radiology
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