The following data is part of a premarket notification filed by Jakoubek Medizintechnik Gmbh with the FDA for Trocar & Trocar Sleeves, Laparoscopes, Laparoscopic Forceps, & Laparoscopic Instruments.
| Device ID | K990785 |
| 510k Number | K990785 |
| Device Name: | TROCAR & TROCAR SLEEVES, LAPAROSCOPES, LAPAROSCOPIC FORCEPS, & LAPAROSCOPIC INSTRUMENTS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | JAKOUBEK MEDIZINTECHNIK GMBH 1822 N. STRATFORD RD. Arlington Hts., IL 60004 |
| Contact | Douglas Hulfish |
| Correspondent | Douglas Hulfish JAKOUBEK MEDIZINTECHNIK GMBH 1822 N. STRATFORD RD. Arlington Hts., IL 60004 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-09 |
| Decision Date | 1999-08-27 |