The following data is part of a premarket notification filed by Hurricane Medical with the FDA for Drainage Wick; Surgical Spears And Sponges, Corneal Light Shield, Instrument Wipe.
| Device ID | K990671 |
| 510k Number | K990671 |
| Device Name: | DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE |
| Classification | Sponge, Ophthalmic |
| Applicant | HURRICANE MEDICAL 2331K 63RD AVE. EAST Bradenton, FL 34203 |
| Contact | David A Clapp |
| Correspondent | David A Clapp HURRICANE MEDICAL 2331K 63RD AVE. EAST Bradenton, FL 34203 |
| Product Code | HOZ |
| CFR Regulation Number | 886.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-02 |
| Decision Date | 1999-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813465012224 | K990671 | 000 |
| 00813465011302 | K990671 | 000 |
| 00813465011333 | K990671 | 000 |
| 00813465011340 | K990671 | 000 |
| 00813465011364 | K990671 | 000 |
| 00813465012019 | K990671 | 000 |
| 00813465012064 | K990671 | 000 |
| 00813465012118 | K990671 | 000 |
| 00813465012026 | K990671 | 000 |
| 00813465012033 | K990671 | 000 |
| 00813465012057 | K990671 | 000 |
| 00813465012088 | K990671 | 000 |
| 00813465012095 | K990671 | 000 |
| 00813465012217 | K990671 | 000 |
| 00813465011296 | K990671 | 000 |