The following data is part of a premarket notification filed by Technical Products, Inc. with the FDA for Sil-tec Nonreinforced Sheeting, Reinforced Sheeting, Radiopaque Sheeting, Reinforced Radiopaque Sheeting, Extra Firm Gra.
| Device ID | K971472 |
| 510k Number | K971472 |
| Device Name: | SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | TECHNICAL PRODUCTS, INC. 2416 PARK CENTRAL BLVD. Decatur, GA 30035 |
| Contact | Norbert D Thompson |
| Correspondent | Norbert D Thompson TECHNICAL PRODUCTS, INC. 2416 PARK CENTRAL BLVD. Decatur, GA 30035 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-23 |
| Decision Date | 1997-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B05150064X80 | K971472 | 000 |
| B05150034X40 | K971472 | 000 |
| B051500312X120 | K971472 | 000 |
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| B0515011S12120 | K971472 | 000 |
| B05150116X80 | K971472 | 000 |
| B0515006S480 | K971472 | 000 |