The following data is part of a premarket notification filed by Medical Technical Products with the FDA for Medical Technical Products Standard Ultrasonic Handpiece.
| Device ID | K940088 |
| 510k Number | K940088 |
| Device Name: | MEDICAL TECHNICAL PRODUCTS STANDARD ULTRASONIC HANDPIECE |
| Classification | Unit, Phacofragmentation |
| Applicant | MEDICAL TECHNICAL PRODUCTS 23042 ALCALDE, SUITE A Laguna Hills, CA 92653 |
| Contact | James H Bakos |
| Correspondent | James H Bakos MEDICAL TECHNICAL PRODUCTS 23042 ALCALDE, SUITE A Laguna Hills, CA 92653 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-07 |
| Decision Date | 1994-08-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850039020117 | K940088 | 000 |
| 00850039020100 | K940088 | 000 |
| 00850039020094 | K940088 | 000 |
| 00850039020087 | K940088 | 000 |