The following data is part of a premarket notification filed by Perlink Usa, Inc. with the FDA for Perlink Cassette, Kiran Cassette.
| Device ID | K896708 |
| 510k Number | K896708 |
| Device Name: | PERLINK CASSETTE, KIRAN CASSETTE |
| Classification | Cassette, Radiographic Film |
| Applicant | PERLINK USA, INC. 290 STULYVESANT AVE. Rye, NY 10580 |
| Contact | Sushil K Kanwar |
| Correspondent | Sushil K Kanwar PERLINK USA, INC. 290 STULYVESANT AVE. Rye, NY 10580 |
| Product Code | IXA |
| CFR Regulation Number | 892.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-28 |
| Decision Date | 1990-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60889976807125 | K896708 | 000 |
| 60889976805657 | K896708 | 000 |
| 60889976805664 | K896708 | 000 |
| 60889976805695 | K896708 | 000 |
| 60889976805701 | K896708 | 000 |
| 60889976805718 | K896708 | 000 |
| 60889976805732 | K896708 | 000 |
| 60889976805756 | K896708 | 000 |
| 60889976805763 | K896708 | 000 |
| 60889976805770 | K896708 | 000 |
| 60889976807002 | K896708 | 000 |
| 60889976807033 | K896708 | 000 |
| 60889976807064 | K896708 | 000 |
| 60889976807071 | K896708 | 000 |
| 60889976807088 | K896708 | 000 |
| 60889976807095 | K896708 | 000 |
| 60889976807101 | K896708 | 000 |
| 60889976805640 | K896708 | 000 |