The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Surgical Vascular Clamp.
Device ID | K973080 |
510k Number | K973080 |
Device Name: | SURGICAL VASCULAR CLAMP |
Classification | Clamp, Vascular |
Applicant | WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
Contact | Diana Preston |
Correspondent | Diana Preston WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
Product Code | DXC |
CFR Regulation Number | 870.4450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-18 |
Decision Date | 1998-02-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00841036162122 | K973080 | 000 |
00841036025168 | K973080 | 000 |
00841036025182 | K973080 | 000 |
00841036044527 | K973080 | 000 |
00841036044534 | K973080 | 000 |
00841036044725 | K973080 | 000 |
00841036044732 | K973080 | 000 |
00841036044749 | K973080 | 000 |
00841036044756 | K973080 | 000 |
00841036044794 | K973080 | 000 |
00841036045067 | K973080 | 000 |
00841036045494 | K973080 | 000 |
00841036080617 | K973080 | 000 |
00841036138165 | K973080 | 000 |
00841036140762 | K973080 | 000 |
00841036025137 | K973080 | 000 |