Atlas FDA

STERI-LOK DUAL PURPOSE PACKAGING/8400

FDA 510(k) clearance K811670 · decided 1981-07-10

Clearance details

K-number
K811670
Device name
STERI-LOK DUAL PURPOSE PACKAGING/8400
Applicant
3M Company
Decision
Substantially Equivalent
Date received
1981-06-15
Decision date
1981-07-10
Days to decision
25 days
Clearance type
Traditional
Product code
FRG
Device class
2
Regulation number
880.6850
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
White City, OR, 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