The following data is part of a premarket notification filed by Endoscopic Concepts, Inc. with the FDA for Sabre Multi-use Trocar System.
Device ID | K952977 |
510k Number | K952977 |
Device Name: | SABRE MULTI-USE TROCAR SYSTEM |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | ENDOSCOPIC CONCEPTS, INC. 11 FOREST PARK DR. Mendon, MA 01756 |
Contact | J. A. Wilson |
Correspondent | J. A. Wilson ENDOSCOPIC CONCEPTS, INC. 11 FOREST PARK DR. Mendon, MA 01756 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-27 |
Decision Date | 1995-07-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
40653405039045 | K952977 | 000 |
20653405036491 | K952977 | 000 |
20653405036484 | K952977 | 000 |
10884521081376 | K952977 | 000 |
10884521081369 | K952977 | 000 |
10884521081321 | K952977 | 000 |
10884521081307 | K952977 | 000 |
10884521081284 | K952977 | 000 |
10884521081260 | K952977 | 000 |
10884521081246 | K952977 | 000 |
00653405036626 | K952977 | 000 |
00653405036619 | K952977 | 000 |
00653405036602 | K952977 | 000 |
00653405036596 | K952977 | 000 |
00653405036589 | K952977 | 000 |
00653405036572 | K952977 | 000 |
00653405036565 | K952977 | 000 |
20653405036507 | K952977 | 000 |
20653405036514 | K952977 | 000 |
20653405036521 | K952977 | 000 |
40653405039014 | K952977 | 000 |
30653405038171 | K952977 | 000 |
40653405037096 | K952977 | 000 |
40653405037089 | K952977 | 000 |
40653405037072 | K952977 | 000 |
40653405037065 | K952977 | 000 |
20653405037054 | K952977 | 000 |
20653405037047 | K952977 | 000 |
40653405037034 | K952977 | 000 |
20653405036682 | K952977 | 000 |
20653405036675 | K952977 | 000 |
20653405036668 | K952977 | 000 |
20653405036651 | K952977 | 000 |
40653405036648 | K952977 | 000 |
40653405036631 | K952977 | 000 |
20653405036545 | K952977 | 000 |
00653405036558 | K952977 | 000 |