The following data is part of a premarket notification filed by Pleasure Latex Products Sdn. Bhd. with the FDA for Latex Ultrasonic Probe Cover.
| Device ID | K022156 |
| 510k Number | K022156 |
| Device Name: | LATEX ULTRASONIC PROBE COVER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | PLEASURE LATEX PRODUCTS SDN. BHD. LOT 1365, 17TH MILES, JALAN SUNGAI SEMBILANG Jeram, Selangor Darul Ehsan, MY 45800 |
| Contact | Koi-yong Lim |
| Correspondent | Koi-yong Lim PLEASURE LATEX PRODUCTS SDN. BHD. LOT 1365, 17TH MILES, JALAN SUNGAI SEMBILANG Jeram, Selangor Darul Ehsan, MY 45800 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-02 |
| Decision Date | 2003-09-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784124834 | K022156 | 000 |
| 20612479224333 | K022156 | 000 |
| 20612479202850 | K022156 | 000 |
| 20612479202836 | K022156 | 000 |
| 20612479185597 | K022156 | 000 |
| 20612479185566 | K022156 | 000 |
| 20612479185535 | K022156 | 000 |