The following data is part of a premarket notification filed by Protek Medical Products, Inc. with the FDA for Drape, Surgical-latex.
| Device ID | K970891 |
| 510k Number | K970891 |
| Device Name: | DRAPE, SURGICAL-LATEX |
| Classification | Drape, Surgical |
| Applicant | PROTEK MEDICAL PRODUCTS, INC. 221 E. MARKET ST. SUITE 291 Iowa City, IA 52245 |
| Contact | Rick L Pruter |
| Correspondent | Rick L Pruter PROTEK MEDICAL PRODUCTS, INC. 221 E. MARKET ST. SUITE 291 Iowa City, IA 52245 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-11 |
| Decision Date | 1997-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841912105608 | K970891 | 000 |
| 30841912104070 | K970891 | 000 |
| 30841912100928 | K970891 | 000 |
| 20841912104073 | K970891 | 000 |
| 20841912100921 | K970891 | 000 |
| 20841912100891 | K970891 | 000 |
| 10841912106070 | K970891 | 000 |
| 00841912105342 | K970891 | 000 |
| 10841912101488 | K970891 | 000 |
| 10841912106117 | K970891 | 000 |
| 10841912105950 | K970891 | 000 |
| 40841912100925 | K970891 | 000 |
| 10841912100870 | K970891 | 000 |
| 10841912105592 | K970891 | 000 |
| 10841912105271 | K970891 | 000 |
| 10841912105202 | K970891 | 000 |
| 10841912105141 | K970891 | 000 |
| 10841912105103 | K970891 | 000 |
| 10841912104991 | K970891 | 000 |
| 10841912104984 | K970891 | 000 |
| 00841912104321 | K970891 | 000 |
| 10841912100917 | K970891 | 000 |
| 10841912100887 | K970891 | 000 |
| 10841912105707 | K970891 | 000 |