The following data is part of a premarket notification filed by Pmt Corp. with the FDA for Pmt Fukushima Microsurgical Instrument Line.
Device ID | K882793 |
510k Number | K882793 |
Device Name: | PMT FUKUSHIMA MICROSURGICAL INSTRUMENT LINE |
Classification | Spatula, Surgical, General & Plastic Surgery |
Applicant | PMT CORP. 1500 PARK RD. Chanhassen, MN 55317 |
Contact | Alfred A Iversen |
Correspondent | Alfred A Iversen PMT CORP. 1500 PARK RD. Chanhassen, MN 55317 |
Product Code | GAF |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-06 |
Decision Date | 1988-07-18 |