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 |