The following data is part of a premarket notification filed by Medical Technique Instruments, Inc. with the FDA for Microscope Drape.
| Device ID | K902851 |
| 510k Number | K902851 |
| Device Name: | MICROSCOPE DRAPE |
| Classification | Drape, Microscope, Ophthalmic |
| Applicant | MEDICAL TECHNIQUE INSTRUMENTS, INC. 16541 REDMOND WAY SUITE 362-C Redmond, WA 98052 |
| Contact | Lou Castagna |
| Correspondent | Lou Castagna MEDICAL TECHNIQUE INSTRUMENTS, INC. 16541 REDMOND WAY SUITE 362-C Redmond, WA 98052 |
| Product Code | HMW |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-29 |
| Decision Date | 1990-09-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20885403133890 | K902851 | 000 |
| 20885403067539 | K902851 | 000 |
| 10885403067600 | K902851 | 000 |