The following data is part of a premarket notification filed by Tti Medical with the FDA for Double Puncture Co2 Laser Laparoscopy Set.
| Device ID | K870046 |
| 510k Number | K870046 |
| Device Name: | DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET |
| Classification | Laser, Surgical, Gynecologic |
| Applicant | TTI MEDICAL 3470 MT. DIABLO BLVD. SUITE A 150 Lafayette, CA 94549 |
| Contact | Allen R Howes |
| Correspondent | Allen R Howes TTI MEDICAL 3470 MT. DIABLO BLVD. SUITE A 150 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 | 1987-01-05 |
| Decision Date | 1987-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B1773185AS750 | K870046 | 000 |
| B17731160 | K870046 | 000 |
| B1773113WOL80 | K870046 | 000 |
| B1773113WOL50 | K870046 | 000 |
| B1773113STR50 | K870046 | 000 |
| B1773113STO750 | K870046 | 000 |
| B1773113STD60 | K870046 | 000 |
| B1773113STD510 | K870046 | 000 |
| B1773113OLY50 | K870046 | 000 |
| B1773113CAB60 | K870046 | 000 |
| B17731250 | K870046 | 000 |
| B17731810 | K870046 | 000 |
| B1773181AS50 | K870046 | 000 |
| B1773184AS80 | K870046 | 000 |
| B1773184AS50 | K870046 | 000 |
| B1773183AS60 | K870046 | 000 |
| B1773182AS50 | K870046 | 000 |
| B1773181AS6S0 | K870046 | 000 |
| B1773181AS60 | K870046 | 000 |
| B1773181AS510 | K870046 | 000 |
| B1773181AS50020 | K870046 | 000 |
| B1773181AS50010 | K870046 | 000 |
| B17731130 | K870046 | 000 |