The following data is part of a premarket notification filed by Hk Surgical, Inc. with the FDA for Klein Touch Pump And Disposable Tubing Set.
| Device ID | K123822 |
| 510k Number | K123822 |
| Device Name: | KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET |
| Classification | Pump, Infusion |
| Applicant | HK SURGICAL, INC. 1271 PUERTA DEL SOL San Clemente, CA 92673 |
| Contact | Clare Bennett |
| Correspondent | Clare Bennett HK SURGICAL, INC. 1271 PUERTA DEL SOL San Clemente, CA 92673 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-12 |
| Decision Date | 2013-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08169890200142 | K123822 | 000 |
| 00816989021123 | K123822 | 000 |