The following data is part of a premarket notification filed by Transamerican Technologies Intl. with the FDA for Co2 Laser Micromanipulator.
| Device ID | K864378 |
| 510k Number | K864378 |
| Device Name: | CO2 LASER MICROMANIPULATOR |
| Classification | Laser, Surgical, Gynecologic |
| Applicant | TRANSAMERICAN TECHNOLOGIES INTL. 3470 MT. DIABLO BOULEVARD, SUITE A150 Lafayette, CA 94549 |
| Contact | Allen R Howes |
| Correspondent | Allen R Howes TRANSAMERICAN TECHNOLOGIES INTL. 3470 MT. DIABLO BOULEVARD, SUITE A150 Lafayette, CA 94549 |
| Product Code | HHR |
| CFR Regulation Number | 884.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-05 |
| Decision Date | 1987-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B17770560 | K864378 | 000 |
| B17711110 | K864378 | 000 |
| B17711120 | K864378 | 000 |
| B17711150 | K864378 | 000 |
| B17711160 | K864378 | 000 |
| B17711170 | K864378 | 000 |
| B17711180 | K864378 | 000 |
| B17711210 | K864378 | 000 |
| B17711220 | K864378 | 000 |
| B17770040 | K864378 | 000 |
| B1777004S0 | K864378 | 000 |
| B17770060 | K864378 | 000 |
| B17770080 | K864378 | 000 |
| B17770090 | K864378 | 000 |
| B17770210 | K864378 | 000 |
| B17770220 | K864378 | 000 |
| B17711100 | K864378 | 000 |
| B17711090 | K864378 | 000 |
| B177A55014900TTI0 | K864378 | 000 |
| B1771109R0 | K864378 | 000 |
| B1777065PL0 | K864378 | 000 |
| B17770690 | K864378 | 000 |
| B1777040ES0 | K864378 | 000 |
| B17711230 | K864378 | 000 |
| B17704342043D0 | K864378 | 000 |
| B17704342044C0 | K864378 | 000 |
| B17711010 | K864378 | 000 |
| B17711020 | K864378 | 000 |
| B17711030 | K864378 | 000 |
| B17711040 | K864378 | 000 |
| B17711050 | K864378 | 000 |
| B17711060 | K864378 | 000 |
| B17711080 | K864378 | 000 |
| B17770280 | K864378 | 000 |
| B17770290 | K864378 | 000 |
| B17770310 | K864378 | 000 |
| B17770650 | K864378 | 000 |
| B1777065P0 | K864378 | 000 |
| B17770660 | K864378 | 000 |
| B17770670 | K864378 | 000 |
| B17770680 | K864378 | 000 |
| B17770770 | K864378 | 000 |
| B17770800 | K864378 | 000 |
| B17770810 | K864378 | 000 |
| B17770820 | K864378 | 000 |
| B17770830 | K864378 | 000 |
| B17770840 | K864378 | 000 |
| B17770860 | K864378 | 000 |
| B17770890 | K864378 | 000 |
| B17770920 | K864378 | 000 |
| B17770940 | K864378 | 000 |
| B17770640 | K864378 | 000 |
| B17770630 | K864378 | 000 |
| B17770400 | K864378 | 000 |
| B17770410 | K864378 | 000 |
| B17770420 | K864378 | 000 |
| B17770430 | K864378 | 000 |
| B17770440 | K864378 | 000 |
| B177704420 | K864378 | 000 |
| B17770460 | K864378 | 000 |
| B17770500 | K864378 | 000 |
| B17770510 | K864378 | 000 |
| B17770540 | K864378 | 000 |
| B17770550 | K864378 | 000 |
| B17770550030 | K864378 | 000 |
| B17770560010 | K864378 | 000 |
| B17770560020 | K864378 | 000 |
| B17770620 | K864378 | 000 |
| B17770960 | K864378 | 000 |