Device Classification Name |
Sponge, Ophthalmic
|
510(k) Number |
K974313 |
Device Name |
HYDROFERA SURGICAL SPEAR |
Applicant |
HYDROFERA, LLC. |
322 MAIN ST., SUITE 1101 |
WILLIMANTIC,
CT
06226
|
|
Applicant Contact |
HEATHER S BOND |
Correspondent |
HYDROFERA, LLC. |
322 MAIN ST., SUITE 1101 |
WILLIMANTIC,
CT
06226
|
|
Correspondent Contact |
HEATHER S BOND |
Regulation Number | 886.4790
|
Classification Product Code |
|
Date Received | 11/17/1997 |
Decision Date | 03/02/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|