The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Alcon Surgical Sponge.
| Device ID | K896004 |
| 510k Number | K896004 |
| Device Name: | ALCON SURGICAL SPONGE |
| Classification | Sponge, Ophthalmic |
| Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
| Contact | Rebecca G Walker |
| Correspondent | Rebecca G Walker ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
| Product Code | HOZ |
| CFR Regulation Number | 886.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-13 |
| Decision Date | 1989-11-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10380651000107 | K896004 | 000 |
| 10380651000060 | K896004 | 000 |
| 10380651000039 | K896004 | 000 |
| 10380651000022 | K896004 | 000 |
| 10889942283408 | K896004 | 000 |