The following data is part of a premarket notification filed by Kay Elemetrics Corp. with the FDA for 9105 Rigid Telescopic Endoscope.
| Device ID | K921285 |
| 510k Number | K921285 |
| Device Name: | 9105 RIGID TELESCOPIC ENDOSCOPE |
| Classification | Laryngostroboscope |
| Applicant | KAY ELEMETRICS CORP. 12 MAPLE AVE. P.O. BOX 2025 Pine Brook, NJ 07058 |
| Contact | William Harbeson |
| Correspondent | William Harbeson KAY ELEMETRICS CORP. 12 MAPLE AVE. P.O. BOX 2025 Pine Brook, NJ 07058 |
| Product Code | EQL |
| CFR Regulation Number | 874.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-17 |
| Decision Date | 1992-05-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333240692 | K921285 | 000 |
| 04961333240586 | K921285 | 000 |
| 04961333240579 | K921285 | 000 |
| 04961333240562 | K921285 | 000 |
| 04961333240548 | K921285 | 000 |
| 04961333240531 | K921285 | 000 |