The following data is part of a premarket notification filed by Plastic Manufacturing And Marketing Group, Inc. with the FDA for I.v. Roller Guard Clamp.
| Device ID | K942446 |
| 510k Number | K942446 |
| Device Name: | I.V. ROLLER GUARD CLAMP |
| Classification | Set, Administration, Intravascular |
| Applicant | PLASTIC MANUFACTURING AND MARKETING GROUP, INC. P.O. BOX 1481 Lanesboro, MA 01237 |
| Contact | Erik J Kristensen |
| Correspondent | Erik J Kristensen PLASTIC MANUFACTURING AND MARKETING GROUP, INC. P.O. BOX 1481 Lanesboro, MA 01237 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-23 |
| Decision Date | 1995-02-17 |