The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Alcon Surgical Procedure Packs.
| Device ID | K880961 |
| 510k Number | K880961 |
| Device Name: | ALCON SURGICAL PROCEDURE PACKS |
| Classification | General Surgery Tray |
| Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY PO BOX 6600 Fort Worth, TX 76134 -2099 |
| Contact | Rebecca G Walker |
| Correspondent | Rebecca G Walker ALCON LABORATORIES 6201 SOUTH FREEWAY PO BOX 6600 Fort Worth, TX 76134 -2099 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-08 |
| Decision Date | 1988-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H5302ALCON2CPAK20 | K880961 | 000 |
| H5301ALCON1CPAK10 | K880961 | 000 |