The following data is part of a premarket notification filed by Prescient Surgical, Inc. with the FDA for Cleancision Wound Retraction And Protection System.
Device ID | K172132 |
510k Number | K172132 |
Device Name: | CleanCision Wound Retraction And Protection System |
Classification | Wound Retraction And Protection System |
Applicant | Prescient Surgical, Inc. 1585 Industrial Rd. San Carlos, CA 94070 |
Contact | Lisa Claude |
Correspondent | Lisa Claude Prescient Surgical, Inc. 1585 Industrial Rd. San Carlos, CA 94070 |
Product Code | PQI |
CFR Regulation Number | 878.4371 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-14 |
Decision Date | 2017-10-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
28685320003014 | K172132 | 000 |
28685320003007 | K172132 | 000 |