Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyamide
|
510(k) Number |
K981582 |
Device Name |
SURGILON, DERMALON, & OPHTHALON |
Applicant |
DAVIS & GECK, INC. |
444 MC DONNELL BLVD. |
HAZELWOOD,
MO
63042
|
|
Applicant Contact |
VANADA JOHNSON |
Correspondent |
DAVIS & GECK, INC. |
444 MC DONNELL BLVD. |
HAZELWOOD,
MO
63042
|
|
Correspondent Contact |
VANADA JOHNSON |
Regulation Number | 878.5020
|
Classification Product Code |
|
Date Received | 05/04/1998 |
Decision Date | 07/13/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|