The following data is part of a premarket notification filed by Retraction Limited with the FDA for Reveel Endoscopic Retractor.
Device ID | K133345 |
510k Number | K133345 |
Device Name: | REVEEL ENDOSCOPIC RETRACTOR |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | RETRACTION LIMITED UNIT F, 2/F, HONG KONG INDUSTRIAL BLDG 444-452 DES VOEUX ROAD WEST Sai Wan, Hong Kong, CN 999077 |
Contact | Stuart Moran |
Correspondent | Stuart Moran RETRACTION LIMITED UNIT F, 2/F, HONG KONG INDUSTRIAL BLDG 444-452 DES VOEUX ROAD WEST Sai Wan, Hong Kong, CN 999077 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-10-30 |
Decision Date | 2014-04-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00811099014423 | K133345 | 000 |
00811099014393 | K133345 | 000 |