The following data is part of a premarket notification filed by Precision Medical, Inc. with the FDA for Pm9000 Vac Trap.
Device ID | K941818 |
510k Number | K941818 |
Device Name: | PM9000 VAC TRAP |
Classification | Bottle, Collection, Vacuum |
Applicant | PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
Contact | Michael A Krupa |
Correspondent | Michael A Krupa PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
Product Code | KDQ |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-13 |
Decision Date | 1994-12-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00855887006641 | K941818 | 000 |
00850027043487 | K941818 | 000 |
00850027043463 | K941818 | 000 |