The following data is part of a premarket notification filed by Medi-flex Hospital Products, Inc. with the FDA for K-klosure 2 Inch Length/4 Inch Length/8 Inch Length/12 Inch Length.
| Device ID | K970441 |
| 510k Number | K970441 |
| Device Name: | K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH |
| Classification | Strip, Adhesive, Closure, Skin |
| Applicant | MEDI-FLEX HOSPITAL PRODUCTS, INC. 8717 W. 110TH ST., SUITE 750 Overland Park, KS 66210 -2103 |
| Contact | Pat Mcgrath |
| Correspondent | Pat Mcgrath MEDI-FLEX HOSPITAL PRODUCTS, INC. 8717 W. 110TH ST., SUITE 750 Overland Park, KS 66210 -2103 |
| Product Code | FPX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-05 |
| Decision Date | 1997-05-09 |