The following data is part of a premarket notification filed by Microspecialties, Inc. with the FDA for Keratome Blade 200200 & 600600.
| Device ID | K020482 |
| 510k Number | K020482 |
| Device Name: | KERATOME BLADE 200200 & 600600 |
| Classification | Keratome, Ac-powered |
| Applicant | MICROSPECIALTIES, INC. 264 QUARRY RD. Milford, CT 06460 |
| Contact | Charles Vassallo |
| Correspondent | Charles Vassallo MICROSPECIALTIES, INC. 264 QUARRY RD. Milford, CT 06460 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-13 |
| Decision Date | 2002-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30810003222191 | K020482 | 000 |
| 30810003221149 | K020482 | 000 |
| 30810003221132 | K020482 | 000 |
| 30810003221125 | K020482 | 000 |
| 30810003221118 | K020482 | 000 |
| 30810003221101 | K020482 | 000 |
| 30810003221095 | K020482 | 000 |
| 30810003221088 | K020482 | 000 |
| 30810003221071 | K020482 | 000 |
| 30810003221064 | K020482 | 000 |
| 30810003221057 | K020482 | 000 |
| 30810003221156 | K020482 | 000 |
| 30810003221163 | K020482 | 000 |
| 30810003222184 | K020482 | 000 |
| 30810003222177 | K020482 | 000 |
| 30810003222160 | K020482 | 000 |
| 30810003222153 | K020482 | 000 |
| 30810003222146 | K020482 | 000 |
| 30810003222139 | K020482 | 000 |
| 30810003221958 | K020482 | 000 |
| 30810003221521 | K020482 | 000 |
| 30810003221330 | K020482 | 000 |
| 30810003221170 | K020482 | 000 |
| 30810003221040 | K020482 | 000 |